BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1920624 · Received December 13, 2010

    Report

    Report Number
    1823260-2010-07371
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 30, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. A PRE-ANALYTICAL HANDLING PROBLEM IS SUSPECTED, HOWEVER THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW RESULTS FOR CALCIUM (CA) INTERMITTENTLY ON THE ADDITIONAL P MODULE ANALYZER. FIVE PATIENT SAMPLES WERE INVOLVED IN THE EVENT AND WERE DISCREPANT. PATIENT SAMPLE 1, THE ORIGINAL RESULT WAS 6.9 MG/DL; THE ANALYZER AUTO REPEATED THE SAMPLE WHICH YIELDED A RESULT OF 8.7 MG/DL. THE CA RESULT OF 8.7 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 2, THE ORIGINAL RESULT WAS 2.5 MG/DL; AUTO REPEAT RESULT WAS 8.6 MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT P MODULE IN THE LABORATORY WHICH YIELDED A RESULT OF 9.9 MG/DL. THE CA RESULT OF 9.9 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 3, THE ORIGINAL RESULT WAS 5.2 MG/DL; AUTO REPEAT RESULT WAS 7.6 MG/DL. SAMPLE REPEATED ON DIFFERENT P MODULE YIELDED A RESULT OF 8.8 MG/DL. THE CA RESULT OF 8.8 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 4, THE ORIGINAL RESULT WAS 6.5 MG/DL; SAMPLE WAS REPEATED TWICE ON ORIGINAL ANALYZER WHICH YIELDED RESULTS OF 4.6 AND 6.7 MG/DL. SAMPLE REPEATED ON DIFFERENT P MODULE YIELDED A RESULT OF 6.6 MG/DL. THE CA RESULT OF 6.6 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 5, THE ORIGINAL RESULT WAS 2.6 MG/DL; AUTO REPEAT RESULT WAS 8.4 MG/DL. SAMPLE REPEATED TWO ADDITIONAL TIMES ON ORIGINAL ANALYZER WHICH YIELDED RESULTS OF 7.3 AND 8.6 MG/DL. THE CA RESULT OF 8.6 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT AFFECTED BY THE EVENT, AS NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CALCIUM REAGENT LOT NUMBERS FOR R1 WAS 63012001 AND R2 WAS 62888901. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. PERFORMANCE TESTS WERE RUN AND WITHIN SPECIFICATIONS.

    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