BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1885409 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06423
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE FREE T3 RESULTS OF >32.6 PG/ML FOR 20-25 PATIENT SAMPLES AND QUALITY CONTROL MATERIAL WHEN THE ANALYZER SWITCHED TO A NEW PACK OF REAGENT DURING A TESTING RUN. THE USER PERFORMED CALIBRATION, QUALITY CONTROL AND REPEATED TESTING OF THE PATIENT SAMPLES. THE USER PROVIDED RESULTS FOR FIVE PATIENT SAMPLES WHICH WERE DISCREPANT. PATIENT SAMPLE 1 REPEAT RESULT WAS 2.56 PG/ML. PATIENT SAMPLE 2 FROM A (B)(6) FEMALE, REPEAT RESULT WAS 2.54 PG/ML. PATIENT SAMPLE 3 FROM A (B)(6) FEMALE, REPEAT RESULT WAS 3.32 PG/ML. PATIENT SAMPLE 4 FROM A (B)(6) FEMALE, REPEAT RESULT WAS 2.70 PG/ML. PATIENT SAMPLE 5 FROM A (B)(6) FEMALE, REPEAT RESULT WAS 2.82 PG/ML. THE INITIAL RESULTS WERE RELEASED FOR ALL OF THE PATIENT SAMPLES. THE USER DID NOT BELIEVE ANY PATIENTS WERE ADVERSELY AFFECTED AS THEY WERE ABLE TO CONTACT THE HOSPITAL AND PROVIDE CORRECTED RESULTS IN A TIMELY MANNER. THE FREE T3 REAGENT LOT NUMBER WAS 15681104. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE FREE T3 REAGENT PACK DID NOT HAVE A CURRENT CALIBRATION. THE USER CALIBRATED THE PACK, PERFORMED QUALITY CONTROL AND RAN PATIENT SAMPLES WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR