BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP + HCG URINE STRIP TEST

    MDR report key: 3851858 · Received April 11, 2014

    Report

    Report Number
    2027969-2014-00329
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 HCG CUTOFF URINE CONTROL AND HCG HIGH LEVEL 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 INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECTED TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS FROM TWO PTS WITH THE HENRY SCHEIN ONE STEP + HCG URINE STRIP TEST. NO QUANTITATIVE TEST WAS PERFORMED; QUALITATIVE TEST WAS PERFORMED WHICH GAVE POSITIVE RESULTS (LOD UNK). THE ONLY INFO PROVIDED WAS LAST MENSTRUAL PERIOD ON ONE PATIENT WAS 3 MONTHS AGO AND ON THE SECOND PT ONE MONTH AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221187 HENRY SCHEIN ONE STEP + HCG URINE STRIP TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-101 HCG2110298

    Patients

    Seq Age Sex Outcome Treatment
    1