BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEAVA HCG BASIC II

    MDR report key: 1053245 · Received May 28, 2008

    Report

    Report Number
    3005689981-2008-00023
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    March 13, 2008
    Report Date
    May 28, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 25MIU/ML HCG URINE CONTROL. THE 100MIU/ML AND 207.1IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. CONCLUSION: THE RETENTION STRIPS MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    FALSE NEGATIVE RESULTS OBTAINED WITH ACCEAVA HCG BASIC II. NO DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEAVA HCG BASIC II ONE STEP PREGNANCY TEST (URINE) LCX INNOVACON, INC. 92208 HCG7060200

    Patients

    Seq Age Sex Outcome Treatment
    1