BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG COMBO DEVICE SP BRAND RAPID TEST

    MDR report key: 1952385 · Received January 3, 2011

    Report

    Report Number
    2027969-2011-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT: 20MIU/ML HCG URINE LOT: HCG100223-01, 100MIU/ML HCG URINE LOT: HCG100513-01, 294.2IU/ML HCG URINE LOT: HCG100727-03, 500IU/ML HCG BUFFER LOT: HCG100305-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPEC, DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=4). THE 294.2IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 500IU/ML HCG BUFFER CONTROL YIELDED (B)(6) AT 3 MINUTE READ TIME. (N=1). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECS. VERIFY THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE URINE HCG RESULTS USING THE HCG COMBO DEVICE SP BRAND TEST VS QUANTITATIVE RESULTS OF 166,000MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCG COMBO DEVICE SP BRAND RAPID TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBW515 HCG0070096

    Patients

    Seq Age Sex Outcome Treatment
    1