BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS SELECT HCG URINE CASSETTE

    MDR report key: 1133036 · Received August 22, 2008

    Report

    Report Number
    3005689981-2008-00034
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 21, 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 248. 57IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS OF 3 MINUTES READING TIME. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED. THERE IS NO ABNORMAL FOUND IN BATCH REVIEW AND THE PRODUCT NUMBER, PRODUCT DESCRIPTION AND LOT NUMBER WAS VERIFIED. REP 2008. THE RETAIN EVAL AND MFG DOC REVIEW ARE OK. ---REP (2008).

    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 HCG7080198

    Patients

    Seq Age Sex Outcome Treatment
    1