BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1191587 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07294
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ERRONEOUS CREATININE RESULTS FOR FIVE PATIENT SAMPLES. THREE PATIENT EXAMPLES WERE PROVIDED: SAMPLE 1 INITIAL RESULT 5.8 MG/DL, REPEATED IN 2008 GAVE 1.0 MG/DL. SAMPLE 2 INITIAL RESULT 7.5 MG/DL, REPEATED IN THE SAME DAY GAVE 1.3 MG/DL. SAMPLE 3 TESTED IN THE SAME DAY INITIAL RESULT 11.3 MG/DL, REPEAT RESULT 1.3 MG/DL. ERRONEOUS RESULTS WERE REPORTED AND CORRECTED REPORTS WERE SENT TO PHYSICIAN. NO INFORMATION REGARDING PATIENT TREATMENT WAS PROVIDED BY THE CUSTOMER WHEN REQUESTED. THE USER DETERMINED THERE WAS A PINCHED R2 SYRINGE O-RING AND REPLACED IT. THE FIELD SERVICE REPRESENTATIVE VERIFIED THE REPAIR. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK