BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS SELECT HCG URINE CASSETTE

    MDR report key: 1133040 · Received August 22, 2008

    Report

    Report Number
    3005689981-2008-00036
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    K062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION DEVICE TESTING. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100MIU/ML AND 208.99IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. PROBABLE ROOT CAUSE: VERY DILUTE URINE SPECIMENS MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG AND A FALSE NEGATIVE RESULT MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST. IF PREGNANCY IS STILL SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED 48 HOURS LATER AND TESTED; IT IS STATED IN COMPLAINT INFORMATION THAT THE PATIENT WENT TO ANOTHER CLINIC A FEW DAYS LATER, AND CONFIRMED PREGNANCY AND IT IS KNOWN THAT THE HCG LEVEL WILL DOUBLE EVERY 48 - 72 HOURS. SO THIS MAY CAUSE A NEGATIVE RESULT WITH OUR PRODUCT, BUT A POSITIVE RESULT WAS CONFIRMED A FEW DAYS LATER. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    FALSE NEGATIVE URINE HCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSS SELECT HCG URINE CASSETTE HCG PREGNANCY TEST LCX INNOVACON, INC. FHC-A202-OBC68 HCG7070139

    Patients

    Seq Age Sex Outcome Treatment
    1