BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)

    MDR report key: 4954794 · Received July 30, 2015

    Report

    Report Number
    2027969-2015-00551
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K980736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH 25 MIU/ML HCG URINE/SERUM CUTOFF CONTROL, 3 HIGH LEVEL OF HCG URINE CONTROLS (205.2 IU/ML, 208.6 IU/ML AND 216.8 IU/ML, 500 IU/ML), AND 6 PREGNANT IN 7 WEEKS - 23 WEEKS CLINICAL URINE SAMPLES, 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.

    Description of Event or Problem · 1

    NOTIFICATION RECEIVED FROM DISTRIBUTOR. EVENT OCCURRED IN (B)(6). CUSTOMER COMPLAINT FALSE NEGATIVE HCG RESULTS. REPORTEDLY, PATIENT WAS PREGNANT BUT NO CONFIRMATORY METHOD PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498616 HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM) HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-211B/4-ONN01(25T/B) M04KUS03-86

    Patients

    Seq Age Sex Outcome Treatment
    1