BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 703370 · Received April 13, 2006

    Report

    Report Number
    MW1038632
    Event Type
    Malfunction
    Date Received
    April 13, 2006
    Date of Event
    April 10, 2006
    Report Date
    April 13, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT MALFUNCTION RESULTING IN REPORTING OF ERRONEOUS TEST RESULTS -CK MB AND TROPONIN I-. POST EVENT, ABBOTT TECHNICAL SERVICE DETERMINED THE MALFUNCTION TO BE INSUFFICIENT SAMPLING OF SOLUTION #3 -MATRIX CELL WASH-; HOWEVER, DURING THE PERIOD OF INSTRUMENT MALFUNCTION, RESULTS WERE PRODUCED IN 2 SEPARATE TEST RUNS WHICH CONTAINED NO ERROR CODES OR WARNING FLAGS INDICATIVE OF INSTRUMENT MALFUNCTION TO ALERT THE TECH THAT RESULTS WERE QUESTIONABLE. AS PER STANDARD OPERATING PROCEDURE, CRITICAL TESTS WERE REPEATED AND VERIFIED. DISCOVERY OF MALFUNCTION COMMENCED WHEN MEDICAL TECHNOLOGIST RECOGNIZED UNUSUAL TREND IN THE NUMBER OF POSITIVE TROPONINS, CK MBS, AND HCGS. QUALITY CONTROL WAS RUN WHICH SUBSEQUENTLY FAILED. SAMPLE WAS RETESTED ON 2ND AXSYM WHICH YIELDED CORRECTED RESULTS. CORRECTED REPORT WAS ISSUED AND PROVIDER WAS NOTIFIED. ABBOTT DIAGNOSTICS WERE ENGAGED FOR PROBLEM RESOLUTION. FULL PREVENTIVE MAINTENANCE WAS PERFORMED BY ABBOTT IN 04/06. REGIONAL LAB MGR REQUESTED PLACEMENT OF SENSORS ON ASPIRATING STRAW -REAGENT #3- ALONG WITH A DEFINITIVE REPORT WITH REGARD TO PRODUCT IMPROVEMENT FROM ABBOTT'S ENGINEERING DIVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM JJE ABBOTT DIAGNOSTICS DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other