BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

    MDR report key: 1811234 · Received August 11, 2010

    Report

    Report Number
    2027969-2010-01184
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG100113-01. 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01. 237.6IU/ML HCG URINE CONTROL LOT: HCG100420-01. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. DETAILS AS BELOW: CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MIN READ TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=5). THE 237.6IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MIN READ TIME. (N=5). CONCLUSION: FROM RETAIN TESTING WITH IN-HOUSE CONTROLS, THE CLIENT'S RESULTS 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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POTENTIAL FALSE NEGATIVE URINE HCG RESULTS. NO PT INFO PROVIDED.

    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-KHS100 HCG9110059

    Patients

    Seq Age Sex Outcome Treatment
    1