BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS SELECT HCG URINE/SERUM COMBO

    MDR report key: 1190738 · Received October 6, 2008

    Report

    Report Number
    3005689981-2008-00044
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 6, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    K933065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION DEVICE TESTING CONTROL LOT: 25MIU/ML HCG URINE CONTROL LOT: HCG080821-03, 100MIU/ML HCG URINE CONTROL LOT: HCG071016, 206.0IU/ML HCG URINE CONTROL LOT: HCG080813-01. REFERENCE NOTEBOOK: SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100MIU/ML AND 206.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED. RETURNED DEVICE CONTROL LOT: 25MIU/ML HCG URINE CONTROL LOT: HCG080821-03, 100MIU/ML HCG URINE CONTROL LOT: HCG071016, 206.0IU/ML HCG URINE CONTROL LOT: HCG080813-01. REFERENCE NOTEBOOK: SUMMARY OF RESULTS: THE RETURN DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL AT 3 MINUTES READ TIME. THE 100MIU/ML AND 206.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. CONCLUSION: THE RETURN 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/SERUM COMBO HCG PREGNANCY TEST LCX INNOVACON, INC. FHC-202-KFI30/50 HCG7090051

    Patients

    Seq Age Sex Outcome Treatment
    1