BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

    MDR report key: 1833452 · Received September 8, 2010

    Report

    Report Number
    2027969-2010-01382
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG100113-01; 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01; 228.6IU/ML HCG URINE CONTROL LOT: HCG100420-02; 500IU/ML HCG BUFFER CONTROL LOT: HCG100305-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25 MIU/ML HCG URINE CONTROL AT 3 MINUTE READ TIME. (N=3). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). THE 228.6IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=2). THE 500IU/ML HCG BUFFER CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=2). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULT WAS NOT REPLICATED AND THE PRODUCT PERFORMED AS EXPECTED MEETING QC SPECIFICATIONS. VERIFIED THE PRODUCT NUMBER, PRODUCT DESCRIPTION, LOT NUMBER AND BATCH RECORD; NO ABNORMAL RESULTS WERE FOUND. CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG100727-01; 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01; 237.6IU/ML HCG URINE CONTROL LOT: HCG100420-01. SUMMARY OF RESULTS: THE RETURN DEVICES MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/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 237.6IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). CONCLUSION: FROM RETURN TESTING WITH IN-HOUSE CONTROL, THE CLIENT'S RESULT WAS NOT REPLICATED, AND THE PRODUCT PERFORMED AS EXPECTED. 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 VS. COMPETITOR'S KIT AND SERUM HCG RESULTS ON ONE PATIENT. CUSTOMER DID A COMPARISON WITH A COMPETITOR'S KIT WHICH GAVE "CORRECT" RESULTS. ONE PATIENT HAD A SERUM QUANT OF OVER 300,000MIU/ML.

    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 HCG0010040

    Patients

    Seq Age Sex Outcome Treatment
    1