BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA (800)

    MDR report key: 957491 · Received November 28, 2007

    Report

    Report Number
    1823260-2007-10277
    Event Type
    Malfunction
    Date Received
    November 28, 2007
    Date of Event
    November 8, 2007
    Report Date
    November 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FIVE PATIENTS SAMPLES RECOVERED WITH LOW SODIUM RESULTS. SAME PATIENT SAMPLES WERE RERUN AGAIN. INITIAL RESULTS WERE NOT REPORTED. INITIAL RESULT MMOL/L REPEAT RESULT MMOL/L. PATIENT #1. 132/138, REPEATED AGAIN 137, PATIENT #2. 130/136, REPEATED AGAIN 135, PATIENT #3. 135/141, REPEATED AGAIN 139, PATIENT #4, 132/140, REPEATED TWO MORE TIMES WITH RESULT OF 136 EACH TIME, PATIENT #5. 130/135, REPEATED AGAIN 137. THE FIELD SERVICE REPRESENTATIVE DETERMINED A SEAL WAS MISSING ON A SAMPLE SYRINGE. THE SEAL WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA (800) INTEGRA 800 - JJE JJE ROCHE DIAGNOSTICS INTEGRA 800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR