BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON HCG CASSETTE (25T)

    MDR report key: 3962598 · Received June 28, 2014

    Report

    Report Number
    2027969-2014-00612
    Event Type
    Malfunction
    Date Received
    June 28, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH HCG 25 MIU/ML CUTOFF URINE CONTROL AND 100 MIU/ML HCG URINE CONTROL, ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PATIENT SPECIMEN IN-HOUSE ANALYSIS. BASED ON THE INFORMATION 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

    CUSTOMER REPORTED AN UNCONFIRMED FALSE NEGATIVE URINE HCG RESULT WITH MCKESSON HCG CASSETTE (25T). PATIENT PRESENTED AT FACILITY FOR PREGNANCY TEST; A POSITIVE TEST RESULT IS NEEDED FOR MEDICAID ELIGIBILITY. TEST RESULT WITH THE MCKESSON HCG TEST WAS NEGATIVE. PATIENT TOLD CUSTOMER THAT SHE HAD A URINE PREGNANCY TEST PERFORMED 2 DAYS AGO (NEARBY FACILITY) AND IT WAS POSITIVE. NO QUANTITATIVE SERUM TEST WAS PERFORMED; NO SAMPLE AVAILABLE FOR TESTING. PATIENT IS ON AN ANTIBIOTIC FOR UTI (UNCERTAIN IF BACTRIM). PATIENT'S LAST MENSTRUAL PERIOD: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378583 MCKESSON HCG CASSETTE (25T) JHI ALERE SAN DIEGO INC FHC-102-OBW12 HCG3060208

    Patients

    Seq Age Sex Outcome Treatment
    1