BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPA

    MDR report key: 1925694 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07436
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 20, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED QUESTIONABLE GLUCOSE RESULTS FOR TWO PATIENT SAMPLES WHEN TESTED ON AN ANALYTICAL D MODULE. IT WAS DETERMINED THE ANALYTICAL D MODULE PERFORMED AS INTENDED, HOWEVER, THE SAMPLES MAY NOT HAVE BEEN PROCESSED CORRECTLY BY THE MODULAR PRE-ANALYTICS SYSTEM (MPA). PATIENT 1, INITIAL GLUCOSE RESULT WAS -31 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAMPLE AUTOMATICALLY REPEATED AND RECOVERED 2 MG/DL (ACCOMPANIED BY A DATA FLAG), THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THE SAMPLE BE REPEATED. THE SAMPLE WAS REPEATED ON (B)(6) 2010 AND RECOVERED 51 MG/DL (ACCOMPANIED BY A DATA FLAG). A CORRECTED REPORT WAS SENT BASED ON THE NEW VALUE OF 51 MG/DL. THE PATIENT WAS NOT AFFECTED BY THE EVENT, THE INITIAL RESULT WAS NOT ACTED ON BY THE PHYSICIAN. PATIENT 2, INITIAL GLUCOSE RESULT WAS 102 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN REQUESTED THE SAMPLE BE REPEATED BECAUSE HE NOTICED A DIFFERENCE BETWEEN THE 102 MG/DL RESULT AND THEIR POINT OF CARE TESTING RESULT (THIS RESULT WAS NOT PROVIDED). THE SAMPLE WAS REPEATED ON (B)(6) 2010 AND RECOVERED 153 MG/DL (ACCOMPANIED BY A DATA FLAG). THE PATIENT WAS NOT HARMED BY THE EVENT. THE FIELD SERVICE REPRESENTATIVE FOUND BOTH SAMPLES WERE SHORT DRAW TUBES WITHOUT GEL SEPARATORS. HE COULD NOT DETERMINE IF THE SAMPLES HAD BEEN CENTRIFUGED OR NOT. THE FIELD SERVICE REPRESENTATIVE VERIFIED THE MPA WAS ALIQUOTING SAMPLES PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPA AUTOMATED PREANALYTICAL SYSTEM JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1