BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SHEIN ONE STEP HCG URINE CASSETTE TEST

    MDR report key: 3772002 · Received December 31, 2013

    Report

    Report Number
    2027969-2013-01147
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 10, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 100 MIU/ML HCG URINE CONTROLS. 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. 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 POTENTIAL FALSE NEGATIVE URINE HCG TEST RESULT WITH (B)(4) ONE STEP HCG URINE CASSETTE TEST VS POSITIVE SERUM HCG RESULTS. A FEMALE PT IN HER TWENTIES WAS TESTED TO CONFIRM POSITIVE RESULTS WITH HOME PREGNANCY TEST. THE URINE HCG TEST PERFORMED USING THE (B)(4) ONE STEP HCG URINE CASSETTE TEST GAVE A NEGATIVE RESULT. THE PT WAS IMMEDIATELY TESTED ON SERUM TEST WITH A RESULT OF >300 MIU/ML. THE PHYSICIAN CONFIRMED HER PREGNANCY. NO INVASIVE PROCEDURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683114 HENRY SHEIN ONE STEP HCG URINE CASSETTE TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC FHC-102-KHS25 HCG2090024

    Patients

    Seq Age Sex Outcome Treatment
    1