BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

    MDR report key: 3884156 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00459
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENSION DEVICES WERE TESTED HCG CUTOFF URINE CONTROLS, ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MFG BATCH REVIEW DID NOT UNCOVER ANY ABNORMALITIES. 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 ALLEGING RECEIVING FALSE NEGATIVE HCG RESULTS FROM THREE PTS CONFIRMED TO BE 4-5 WEEKS PREGNANT BY ULTRASOUND. THREE PTS MID (B)(6) YEARS OF AGE HAD A URINE TEST AND TESTED NEGATIVE AT READ TIME. ULTRASOUND CONFIRMED ALL THREE PTS WERE PREGNANT AT LEAST FOUR WEEKS. NO ADVERSE IMPACT ON PTS AS PHYSICIANS DIAGNOSIS WAS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296106 HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC FHC-102-KHS25 HCG3080124

    Patients

    Seq Age Sex Outcome Treatment
    1