BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

    MDR report key: 2080297 · Received March 31, 2011

    Report

    Report Number
    2027969-2011-00677
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL: 25MIU/ML HCG URINE CONTROL LOT: HCG110105-01, 100MIU/ML HCG URINE CONTROL LOT: HCG100513-01; 212.2IU/ML HCG URINE CONTROL LOT: HCG110124-01. 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 MINUTES READ TIME. (N=5). THE 100MIU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=5). THE 212.2IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTE READ TIME. (N=3). 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. INVESTIGATION PENDING ON RETURNED PRODUCT. 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 ON HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST VS QUANTITATIVE RESULT. THE TEST RESULTS WERE NEGATIVE AT 2 MINUTE READ TIME. WHEN THE CASSETTES WERE LEFT AROUND PAST 15 MINUTES, A FAINT LINE APPEARED. THE FIRST PATIENT WAS CALLED BACK FOR A QUANTITATIVE TEST AND WAS FOUND TO BE IN VERY EARLY STAGES OF PREGNANCY (NO VALUES OR TEST BRAND PROVIDED). A SECOND PATIENT WHO WAS MENOPAUSAL WAS ALSO NEGATIVE AT 3-10 MINUTES. AGAIN, AFTER 15 MINUTES, A FAINT LINE APPEARED. PATIENT WAS CALLED BACK IN FOR A QUANTITATIVE TEST AND THE RESULT WAS 6MIU/ML (BELOW THE CUT-OFF LEVEL OF THE URINE TEST). NEITHER SAMPLE WAS FIRST MORNING URINE.

    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 HCG0080118

    Patients

    Seq Age Sex Outcome Treatment
    1