BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-VUE SERUM/URINE HCG

    MDR report key: 3962581 · Received June 28, 2014

    Report

    Report Number
    2027969-2014-00608
    Event Type
    Malfunction
    Date Received
    June 28, 2014
    Date of Event
    January 22, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    JHI
    PMA / PMN Number
    K993065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH HCG 25 MIU/ML CUTOFF URINE CONTROL AND 3 HIGH LEVEL HCG POSITIVE URINE CONTROL, ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PATIENT SPECIMEN IN-HOUSE ANALYSIS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE URINE HCG TEST WITH SURE-VUE SERUM/URINE HCG VS. POSITIVE RESULTS WITH SERUM. CUSTOMER WAS CALLING TO ASK ABOUT THE CUT-OFF FOR THE TEST. THEY WERE TRYING TO DETERMINE WHETHER IT WAS 25 M IU/ML URINE OR SERUM. THEY HAD NO FURTHER PATIENT INFORMATION. THE SERUM QUANT WAS UNK; REPORT SAYS SERUM TEST WAS 'POSITIVE.' NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378584 SURE-VUE SERUM/URINE HCG JHI ALERE SAN DIEGO INC FHC-202-OBC513 HCG3030193

    Patients

    Seq Age Sex Outcome Treatment
    1