BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

    MDR report key: 1942367 · Received December 23, 2010

    Report

    Report Number
    2027969-2010-02272
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF RESULTS: CONTROLS: 25MIU/ML HCG URINE CONTROL LOT: HCG101014-01; 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01; 294.2IU/ML HCG URINE CONTROL LOT: HCG100727-03; 500IU/ML HCG BUFFER CONTROL LOT: HCG100305-01. THE RETENTION DEVICES MEET QC SPEC. SEE DETAILS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25 MIU/ML HCG URINE CONTROL AT 3 MINUTES READING TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 294.2 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 500 IU/ML HCG BUFFER CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=1). CONCLUSION: THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD WERE VERIFIED. NO ABNORMAL RESULTS WERE FOUND. FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED, AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECS. PRODUCT WILL BE INVESTIGATED IF AND WHEN IT IS RETURNED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTS FALSE NEGATIVE URINE HCG RESULTS IN TWO PATIENTS USING THE HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST. BLOOD SAMPLES TESTED POSITIVE FOR HCG ON ANALYZER. PT INFO WAS ONLY PROVIDED FOR ONE PT. QUANTITATIVE SERUM HCG RESULT: 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-102-KHS25 HCG0030128

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR