BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1904494 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06916
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED QUESTIONABLE VITAMIN B12 RESULTS ON 3 PATIENT SAMPLES. RESULTS FROM 1 SAMPLE WERE FOUND TO BE DISCREPANT. THE INITIAL B12 WAS 154.80 PG/ML. THE RESULT WAS NOT RELEASED OUTSIDE THE LABORATORY. THE TEST WAS REPEATED WITH FRESH REAGENT AND YIELDED A B12 OF 347.5 PG/ML. AS THE INITIAL RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY, NO PATIENTS WERE ADVERSELY AFFECTED. INITIAL TESTING WAS PERFORMED WITH B12 REAGENT LOT NUMBER 15894201. REPEAT TESTING WAS PERFORMED WITH LOT NUMBER 15643507. IT WAS NOTED THAT PRIOR TO THE INITIAL TESTING THE REAGENT WAS TAKEN OUT OF THE REFRIGERATOR AND ALLOWED TO WARM FOR ABOUT ONE HALF HOUR BEFORE USE. LABELING REQUIRES THE REAGENT TO BE BROUGHT TO APPROXIMATELY 20C BEFORE USE. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1