BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG COMBO DEVICE SP BRAND RAPID TEST

    MDR report key: 4171062 · Received July 14, 2014

    Report

    Report Number
    2027969-2014-00655
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    March 9, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 HCG 20 MIU/ML CUTOFF URINE CONTROL AND 3 HIGH LEVEL HCG URINE CONTROL, ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MFG BATCH RECORD 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 FOR ONE PT. UNK CONFIRMATION WAS POSITIVE. PT WAS ADMITTED TO ER ON (B)(6) 2014. URINE WAS TESTED NEGATIVE WITHIN READ-TIME. NO SERUM QUANT IS AVAILABLE. PT'S CHART INDICATES THE PT HAD ECTOPIC PREGNANCY CONFIRMED ON (B)(6). URINE COLLECTION TIME IS UNK. PT'S LMP, AGE, HEALTH CONDITION AND MEDICATION HISTORY NOT KNOWN. NO INVASIVE PROCEDURE PERFORMED BASED ON THE FALSE NEGATIVE RESULT. NO SAMPLES WERE SAVED. THE PRODUCT WAS SHIPPED IN GOOD CONDITION AND EXTERNAL CONTROL RESULTS WERE NORMAL UPON RECEIPT. NO ADD'L PT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410583 HCG COMBO DEVICE SP BRAND RAPID TEST HCG COMBO DEVICE SP BRAND RAPID TEST JHI ALERE SAN DIEGO, INC FHC-A202-BOW515 HCG3080046

    Patients

    Seq Age Sex Outcome Treatment
    1