BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1243724 · Received November 25, 2008

    Report

    Report Number
    1823260-2008-08712
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    September 22, 2008
    Report Date
    November 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES OVER THE LAST YEAR. ONLY ONE EXAMPLE COULD BE PROVIDED WHICH OCCURRED IN 2008. INITIAL CALCIUM RESULT WAS 14.9 MG/DL, REPEAT RESULT WAS 14.9 MG/DL AND IN THE NEXT DAY REPEAT RESULT 9.1 MG/DL. INITIAL CREATININE RESULT WAS 1.9 MG/DL, REPEAT RESULT WAS 0.0 MG/DL AND 0.9 MG/DL (DATE PERFORMED IS UNK). INITIAL BICARBONATE RESULT WAS 46 MMOL/L, REPEAT RESULT WAS 20 MMOL/L (DATE PERFORMED IS UNK). INITIAL RESULTS HAD BEEN REPORTED AND PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE AND REMAINED THERE FOR 2 DAYS. PER THE USER, NO CONSEQUENTIAL TREATMENTS WERE GIVEN. USER DOES NOT HAVE DETAILS OF WHAT ACTIONS WERE TAKEN AT THE HOSPITAL. USER PERFORMED CALIBRATION WHICH IMPROVED THE PERFORMANCE OF THE ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization