BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEAVA HCG BASIC II

    MDR report key: 1232686 · Received November 13, 2008

    Report

    Report Number
    3005689981-2008-00051
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    LCX
    PMA / PMN Number
    K993203
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLE EVALUATION: CONTROL LOT: 100MIU/ML HCG URINE CONTROL LOT: HCG081008-01. 25MIU/ML HCG URINE CONTROL LOT: HCG080401-03. 272.1IU/ML HCG URINE CONTROL LOT: HCG080716-03. PAGE 141. SUMMARY OF RESULTS: THE RETENTION DEVICES MET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25MIU/ML HCG URINE CONTROL. THE 100MIU/ML AND 272.1IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. PROBABLY ROOT CAUSE: IT IS STATED IN COMPLAINT INFORMATION THAT URINE TEST WAS NEGATIVE, BUT SERUM QUANT WAS 62MIU/ML. IT IS KNOWN THAT THE HCG LEVEL IN SERUM IN NORMALLY HIGHER THAN IT IS 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 STRIPS MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED. MANUFACTURING DOCUMENTATION REVIEW RESULTS: THERE IS NO ABNORMAL FOUND IN BATCH REVIEW AND THE PRODUCT NUMBER, PRODUCT DESCRIPTION AND LOT NUMBER WAS VERIFIED.

    Description of Event or Problem · 1

    CUSTOMER STATES PROBLEMS WITH ACCEAVA HCG 92208 KIT GIVING NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCEAVA HCG BASIC II HCG PREGNANCY TEST LCX INNOVACON, INC. 92208 HCG8070133

    Patients

    Seq Age Sex Outcome Treatment
    1