BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+HCG URINE CASSETTE TEST

    MDR report key: 3810876 · Received March 20, 2014

    Report

    Report Number
    2027969-2014-00262
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 3 HIGH LEVEL HCG URINE CONTROLS. ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBSERVED. MFG BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. 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 A POTENTIAL FALSE NEGATIVE URINE HCG RESULT ON A SAMPLE FROM A FEMALE PATIENT IN HER TWENTIES WITH HENRY SCHEIN ONE STEP+HCG URINE CASSETTE TEST. THE EXACT TYPE OF CONFIRMATION TESTING IS NOT KNOWN. THE CUSTOMER INDICATED THAT IT WAS TESTED IN THE LAB, METHOD UNKNOWN, POSSIBLE QUALITATIVE TEST. NO PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166638 HENRY SCHEIN ONE STEP+HCG URINE CASSETTE TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-KHS25 HCG2110300

    Patients

    Seq Age Sex Outcome Treatment
    1