BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE ACETAMINOPHEN

    MDR report key: 1904243 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06898
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 16, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LDP
    PMA / PMN Number
    K013757
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING AN API SURVEY FOR CALCIUM AND ACETAMINOPHEN WHEN THE TESTS WERE RUN ON THE COBAS C311 ANALYZER, SERIAL NUMBER (B)(4). OF THE RESULTS PROVIDED, FOUR OF THE ACETAMINOPHEN RESULTS WERE DISCREPANT. FOR SAMPLE 1 THE CUSTOMER REPORTED AN ACETAMINOPHEN OF 67.1 UG/ML TO THE SURVEY; THE EXPECTED RANGE WAS 77.2 - 95.5 UG/ML. THE TEST WAS REPEATED WITH AN ACETAMINOPHEN OF 65.1 UG/ML. AFTER REPLACEMENT WITH NEW REAGENT AND CALIBRATION OF THE ASSAY THE CUSTOMER OBTAINED VALUES OF 81.3 AND 81.8 UG/ML. FOR SAMPLE 2 THE CUSTOMER REPORTED AN ACETAMINOPHEN OF 23.7 UG/ML TO THE SURVEY; THE EXPECTED RANGE WAS 26.8 - 34.9 UG/ML. THE TEST WAS REPEATED WITH AN ACETAMINOPHEN OF 23.4 UG/ML. AFTER REPLACEMENT WITH NEW REAGENT AND CALIBRATION OF THE ASSAY THE CUSTOMER OBTAINED A VALUE OF 28.8 UG/ML. FOR SAMPLE 3 THE CUSTOMER REPORTED AN ACETAMINOPHEN OF 44.9 UG/ML TO THE SURVEY; THE EXPECTED RANGE WAS 53.8 - 84.4 UG/ML. THE TEST WAS REPEATED WITH AN ACETAMINOPHEN OF 44.2 UG/ML. AFTER REPLACEMENT WITH NEW REAGENT AND CALIBRATION OF THE ASSAY THE CUSTOMER OBTAINED VALUES OF 55.0 AND 54.7 UG/ML. FOR SAMPLE 4 THE CUSTOMER REPORTED AN ACETAMINOPHEN OF 28.4 UG/ML TO THE SURVEY; THE EXPECTED RANGE WAS 33.6 - 42.4 UG/ML. THE TEST WAS REPEATED WITH AN ACETAMINOPHEN OF 28.9 UG/ML. AFTER REPLACEMENT WITH NEW REAGENT AND CALIBRATION OF THE ASSAY THE CUSTOMER OBTAINED A VALUE OF 35.0 UG/ML. THERE WERE NO PATIENTS INVOLVED IN THE EVENT, THEREFORE NONE WERE ADVERSELY AFFECTED. QUALITY CONTROLS FOR ACETAMINOPHEN WERE IN RANGE. THE CUSTOMER HAD LAST CALIBRATED THE ASSAY IN (B)(6). THE CUSTOMER STATED THAT ACETAMINOPHEN WAS NOT RUN VERY OFTEN AND, "THEY DID NOT HAVE VERY MANY QC POINTS TO USE FOR TRACKING OR TRENDING," AND THEY BELIEVED THAT LEAD TO RUNNING THE SURVEY ON, "LESS THAN IDEAL REAGENT." THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACETAMINOPHEN COLORIMETRY, ACETAMINOPHEN LDP ROCHE DIAGNOSTICS NA 21110900

    Patients

    Seq Age Sex Outcome Treatment
    1