BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON HCG CASSETTE (25T) 32-102

    MDR report key: 3902850 · Received February 21, 2014

    Report

    Report Number
    2027969-2014-00157
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH CUTOFF HCG URINE CONTROL AND 3 HIGH LEVEL HCG URINE CONTROLS; ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PT SPECIMEN IN-HOUSE ANALYSIS. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE HCG RESULTS. RESULTS AS FOLLOWS: CUSTOMER REPORTS FALSE NEGATIVE RESULTS WITH 3 PTS WHO HAVE RECENTLY UNDERGONE TERMINATIONS AND HAVE FALLING HCG LEVELS WHICH EXCEED THE SENSITIVITY OF 25 IU/ML. PT LEVELS ARE AT 50 IU/ML. NO PT INFO WAS PROVIDED. NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109999 MCKESSON HCG CASSETTE (25T) 32-102 HCG PREGNANCY JHI ALERE SAN DIEGO, INC. FHC-102-OBW12 HCG3050276

    Patients

    Seq Age Sex Outcome Treatment
    1