BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1844260 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05695
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR FERRITIN ON THE ANALYTICAL P MODULE FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1, THE INITIAL FERRITIN RESULT GAVE 12 PG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED GIVING 23 PG/ML. PATIENT SAMPLE 2, THE INITIAL FERRITIN RESULT GAVE 21 PG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED GIVING 39 PG/ML. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THESE DISCREPANCIES. THE FERRITIN REAGENT LOT NUMBER WAS 62168101 ALTHOUGH THE FIELD APPLICATION SPECIALIST (FAS) COULD NOT DETERMINE A CAUSE, IT WAS NOTED MANY BUBBLES WERE FOUND IN THE FERRITIN R1 REAGENT PACK WHICH COULD INDICATE A REAGENT HANDLING OR SHIPMENT ISSUE AS THE CAUSE. THE FAS RAN PERFORMANCE TESTING WITH ALL RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1