BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS SELECT HCG URINE CASSETTE

    MDR report key: 1133038 · Received August 22, 2008

    Report

    Report Number
    3005689981-2008-00035
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 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: IT IS KNOWN THAT THE HCG LEVEL IN SERUM IS NORMALLY HIGHER THAN IN URINE AND URINE SAMPLE WILL BE INFLUENCED BY MANY FACTORS. IF THE PATIENT DRINKS TOO MUCH WATER WHICH WILL DILUTE THE URINE BEFORE THE TEST, 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. 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-OB68 HCG7070138

    Patients

    Seq Age Sex Outcome Treatment
    1