BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TROPONIN-I ADV REAGENT

    MDR report key: 1931549 · Received December 17, 2010

    Report

    Report Number
    1415939-2010-00582
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. A RETAINED KIT OF THE REAGENT LOT IN QUESTION WAS EVALUATED. A COMPREHENSIVE REVIEW OF THE MANUFACTURING DATA FOR THIS LOT WAS PERFORMED AND DID NOT IDENTIFY ANY ISSUE RELATED TO THIS LOT. TESTING WAS PERFORMED USING THIS REAGENT LOT ALONG WITH THE CALIBRATOR AND CONTROL LOTS WERE USED IN THE CUSTOMER LAB WHEN THIS ISSUE WAS OBSERVED. SIX VALID CALIBRATION CURVES WERE OBTAINED AND ALL CONTROLS WERE WITHIN THE PACKAGE INSERT SPECIFICATIONS. THE TEST VALIDITY CRITERIA WERE MET AND THE TESTING DID NOT REVEAL EVENTS OR ISSUES THAT COULD IMPACT THE PERFORMANCE OF THIS REAGENT LOT. A REVIEW OF THE COMPLAINT HISTORY OF THIS REAGENT LOT DID NOT REVEAL ANY ADVERSE TREND FOR PERFORMANCE RELATED ISSUES. FURTHER MORE, AXSYM TROPONIN-I ADV WAS USED AS A REFERENCE MATERIAL FOR IN-HOUSE INVESTIGATIONS ((B)(4)). BASED ON THE INVESTIGATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY WERE IDENTIFIED BEHIND THIS ISSUE AND THE REAGENT LOT IN QUESTION IS CURRENTLY MEETING ITS PERFORMANCE SPECIFICATIONS, SAFETY AND EFFICACY CLAIMS. HOWEVER, THE CUSTOMER WAS REFERRED TO THE ASSAY PACKAGE INSERT WHERE DISCREPANT RESULTS ARE DISCUSSED ALONG WITH THE POSSIBLE CAUSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING FILED FOR AN EX-US PRODUCT (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (B)(4). AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED FALSE POSITIVE RESULTS (0.44 AND 0.46 NG/ML) FOR THE AXSYM TROPONIN I ASSAY. THE SAME PATIENT SAMPLE WAS RETESTED USING TWO OTHER (NON-ABBOTT) METHODS AND GENERATED NEGATIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TROPONIN-I ADV REAGENT FOR THE QUANTITATIVE DETERMINATION OF CARDIAC TROPONIN-I MMI ABBOTT LABORATORIES 91908JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER 7A83-97 SN (B)(4)| AXSYM ANALYZER 7A83-97 SN (B)(4)