BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1580993 · Received December 9, 2009

    Report

    Report Number
    1823260-2009-08295
    Event Type
    Malfunction
    Date Received
    December 9, 2009
    Date of Event
    November 16, 2009
    Report Date
    December 9, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE USER STATED THAT SHE HAD BEEN USING CALCIUM REAGENT LOT 616892-01 WITH NO PROBLEMS, BUT SHE RAN OUT AND PUT OLD LOT 613188-01 ONTO THE ANALYZER. SHE RAN 12 PATIENT PLASMA SAMPLES AND THE RESULTS "WERE OFF". SHE STATED AFTER REPLACING THE REAGENT WITH LOT 616892-01, SHE RERAN THE PATIENT SAMPLES AND THE RESULTS WERE ACCEPTABLE. THE USER PROVIDED RESULTS FOR ELEVEN PATIENT SAMPLES, OF WHICH NINE WERE DISCREPANT. ALL RESULTS ARE IN MG PER DL. ON (B) (6) 2009, SAMPLE 1 INITIAL RESULT WAS 13.1, REPEAT RESULT ON THE SAME LOT WAS 11.1. SAMPLE 2 INITIAL RESULT WAS 10.9, REPEAT RESULT ON THE SAME LOT WAS 9.6. ON (B) (6) 2009, SAMPLE 3 INITIAL RESULT WAS 11.0, REPEAT RESULT ON THE SAME LOT WAS 9.9. SAMPLE 4 INITIAL RESULT WAS 11.8, REPEAT RESULT ON THE SAME LOT WAS 10.2. ON (B) (6) 2009, SAMPLE 5 INITIAL RESULT WAS 11.2, REPEAT RESULT ON THE SAME LOT WAS 9.6. SAMPLE 6 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 11.4, REPEAT RESULT ON LOT 616892-01 WAS 9.6. SAMPLE 7 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 9.6, REPEAT RESULT ON LOT 616892-01 WAS 9.1. SAMPLE 8 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 10.0, REPEAT RESULT ON LOT 616892-01 WAS 9.2. SAMPLE 9 INITIAL RESULT WAS 10.5, REPEAT RESULT ON THE SAME LOT WAS 9.8, REPEAT RESULT ON LOT 616892-01 WAS 9.5. THE USER STATED SHE REPORTED THE LOWEST RESULT FROM THE ORIGINAL AND RERUNS FOR ALL 12 PATIENT SAMPLES. NO ADVERSE REACTION OCCURRED FORM THE REPORTING OF THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER - JJE JFP ROCHE DIAGNOSTICS C111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK