BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW HCG COMBO

    MDR report key: 2052494 · Received March 15, 2011

    Report

    Report Number
    2027969-2011-00510
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    JHI
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT: 20MIU/ML HCG URINE LOT: HCG110216-01. 100MIU/ML HCG URINE LOT: HCG100513-01. 212.2IU/ML HCG URINE LOT: HCG110124-02. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION, 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=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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED NEGATIVE URINE HCG TEST RESULTS ON CLEARVIEW HCG COMBO TEST VS. BLOOD TEST. CALLER REPORTS PATIENT TESTING NEGATIVE ON LATERAL FLOW HCG WITH AFTERNOON URINE. PATIENT BELIEVED THEY MAY BE PREGNANT AND OBTAINED POSITIVE BLOOD TEST RESULT. TEST METHOD AND SPECIFIC RESULT NOT AVAILABLE BY CALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW HCG COMBO HCG PREGNANCY TEST JHI ALERE SAN DIEGO, INC. FHC-A202-OBC509 HCG0060148

    Patients

    Seq Age Sex Outcome Treatment
    1