URGENT FIELD SAFETY NOTICE

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Ref. CL2015‐072_EU Page 1 of 4

URGENT FIELD SAFETY NOTICE

Software Anomaly using enGen™ Laboratory Automation Systems Configured with enGen™ Select v5.0 and Custom or Select v3.2.2 and below

April xx, 2015

URGENT FIELD SAFETY NOTICE

Software Anomaly using enGen™ Laboratory Automation Systems Configured with enGen™ Select v5.0 and Custom or Select v3.2.2 and below

(Product Code ENGEN) Dear Customer,

As part of a Field Safety Corrective Action, the purpose of this notification is to inform you of an Urgent Field Safety Notice involving the following product:

Product Name Affected enGen™ Software Versions enGen™ Laboratory Automation System Select v5.0; Custom or Select v3.2.2 and below

The purpose of this notification is to inform you of a software anomaly regarding the routing of urine samples that require pretreatment for assays using VITROS® Chemistry Products Ca, Mg and PHOS Slides.

Explanation

Urine samples for use with VITROS® Ca, Mg and PHOS Slides require acidification (pretreatment).

The enGen™ System software currently does not route these samples to the Manual High Priority exit location for pretreatment as intended. In addition, the enGen™ System software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. Depending upon the assay, urine samples need to be acidified, alkalized, extracted or not treated prior to being processed on VITROS® Systems. For more information, please see the Question and Answer section on page 3.

Impact to Patient Results

OCD internal testing has confirmed instances where VITROS® 5,1 FS, 4600 or 5600 Systems allowed testing of multiple assays using a single urine specimen, regardless of the pretreatment

requirements for each selected assay, potentially leading to biased patient results. Refer to the bias summary table in the Question and Answer section on page 3 for assays processed on VITROS®

5,1 FS, 4600 or 5600 Systems.

Please discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.

Required Actions

 Do not order VITROS® Ca, Mg and PHOS Slide assays using urine samples with any other assays.

 Do not place urine samples with test requests for VITROS® Ca, Mg and PHOS Slide assays on the track for sorting or routing. Place pretreated urine samples for these assays directly on the analyzer.

 Place this notification near each VITROS® System or with your enGen™ Laboratory Automation System user documentation.

 Complete the Confirmation of Receipt Form and return by April 17, 2015.

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Resolution

enGen™ Select v5.0.1 will be made available in April 2015. This software version includes a

correction for these issues and will be a required update for your enGen™ System. Your Laboratory Automation Support Specialist (LASS) will contact you to schedule an update of your enGen™

System with this new software version.

When your system is configured with enGen™ Select v5.0.1, the urine samples with test requests for VITROS® Ca, Mg and PHOS Slide assays will be handled in the following manner:

 When placed on the track these urine samples will be routed to the Manual High Priority exit location for manual acidification (pretreatment).

 VITROS® Ca, Mg and PHOS Slide assays using urine samples should be ordered only individually or together, but not with any other assays. If invalid test combinations are ordered, the sample will be routed to the Non‐validated High Priority exit location and the test(s) will need to be reordered individually or as valid test combinations.

Contact Information

We are sorry for any inconvenience this may have caused your laboratory. If you have any

additional questions, please call Customer Technical Services at insert appropriate phone number.

Sincerely,

insert appropriate name insert appropriate title

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Questions and Answers

1. What is the potential for obtaining biased results on the enGen™ System if the operator programs assays requiring pretreated urine samples?

 If the operator places non‐acidified urine samples on the enGen™ System with test requests for VITROS® Ca, Mg and PHOS assays, the samples will be sent directly to the VITROS® System, and there is a potential for biased results for these assays.

 If the operator places acidified (pretreated) urine samples on the enGen™ System and orders only VITROS® Ca, Mg and PHOS assays, results for these assays will not be biased.

 If the operator places acidified samples on the enGen™ System and orders a

VITROS® UPRO Slide, AMYL Slide, mALB Reagent and/or THC Reagent assay(s), there is a potential for the results to be biased.

2. What is the amount of bias that can occur when:

 an assay that requires a sample to be acidified is processed on a sample that is not acidified?

 an assay that requires a non‐acidified sample is processed on a sample that is acidified?

The table below shows an example of biased results obtained during internal investigation:

Assay

Recommended Urine Pretreatment

Erroneous Pretreatment

Concentration with Recommended Urine

Pretreatment

Maximum Bias Observed from Erroneous to

Recommended Pretreatment Conventional SI Conventional SI Ca Acidification No Pretreatment 13.61 mg/dL 3.40 mmol/L ‐8.76 mg/dL ‐2.19 mmol/L Mg Acidification No Pretreatment 14.16 mg/dL 5.83 mmol/L ‐12.96 mg/dL ‐5.33 mmol/L PHOS Acidification No Pretreatment 134.22 mg/dL 43.34 mmol/L ‐17.03 mg/dL ‐5.50 mmol/L AMYL No Pretreatment Acidification 433.0 U/L 433.0 U/L ‐394.5 U/L ‐394.5 U/L UPRO No Pretreatment Acidification 5.5 mg/dL 0.055 g/L Results below the Reportable

Measuring Range mALB No Pretreatment Acidification 6.2 mg/dL 62 mg/L +0.95 mg/dL 9.5 mg/L THC No Pretreatment Acidification 19.0 ng/mL 19.0 µg/L ‐3.9 ng/mL ‐3.9 µg/L

3. What actions should I take to avoid these issues until my enGen™ System is configured with enGen™ Select v5.0.1?

 Do not order VITROS® Ca, Mg and PHOS Slide assays using urine samples with any other assays.

 Do not place urine samples for VITROS® Ca, Mg and PHOS Slide assays on the track for sorting or routing. Place pretreated urine samples for these assays directly on the analyzer.

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Questions and Answers, continued

4. Which VITROS^® Systems are affected by this anomaly?

VITROS® 5,1 FS, 4600 and 5600 Systems allowed testing of multiple assays using a single urine specimen, regardless of the acidification requirements for each selected assay.

Customers using VITROS^® 4600/5600 and VITROS^®5,1 FS Systems are being issued separate notification(s) containing specific information and instructions for these systems.

5. Can I determine if this anomaly had previously occurred on my system?

This anomaly occurred if urine samples were processed without the proper pretreatment.

Review your laboratory protocols and discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.