BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1932149 · Received December 17, 2010

    Report

    Report Number
    1823260-2010-07546
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE RESULT FOR C4 TINA-QUANT (C4) ON THE ANALYTICAL P MODULE FOR ONE PATIENT SAMPLE. ALL C4 RESULTS REPORTED IN MG/DL. THE INITIAL RESULT WAS 0.0. THE SAMPLE WAS REPEATED FIVE TIMES WHICH YIELDED RESULTS OF 28.3 AND 0.0 FOUR TIMES RESPECTIVELY. ALL C4 RESULTS OF 0.0 WERE ACCOMPANIED BY DATA FLAGS. THE C4 RESULT OF 28.3 WAS REPORTED OUTSIDE THE LABORATORY. THE USER REPORTED A CORRECTED C4 RESULT OF < 1.5. THE USER SAID THE PATIENT WAS AN OUTPATIENT AND COULD NOT DETERMINE IF THE PATIENT WAS TREATED BASED ON THE ERRONEOUS C4 RESULT REPORTED OUTSIDE THE LABORATORY, BUT STATED THE PATIENT WAS PROBABLY NOT TREATED. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THIS EVENT. THE REAGENT LOT NUMBER FOR C4 WAS 62638401. ALTHOUGH THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE HE NOTED A PROBABLE CLOT IN THE SAMPLE AS A CONTRIBUTING FACTOR FOR THE EVENT. PERFORMANCE TESTS WERE RUN WHICH WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1