BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON MEDI-LAB HCG URINE CASSETTE

    MDR report key: 1232684 · Received November 13, 2008

    Report

    Report Number
    3005689981-2008-00053
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INNOVACON, INC.
    Product Code
    JHI
    PMA / PMN Number
    K993317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL LOT: 100MIU/ML HCG URINE CONTROL LOT: HCG081008-01. 25MIU/ML HCG URINE CONTROL LOT: HCG080401-03. 227.0IU/ML HCG URINE CONTROL LOT: HCG080813-02. 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 227.0IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. PROBABLY ROOT CAUSE: PT 1: IT IS STATED IN COMPLAINT INFO THAT SERUM QUANT DONE 3 WEEKS LATER WAS 100000MIU/ML. GENERALLY, NORMAL PREGNANCIES WILL HAVE THE HCG LEVEL DOUBLE EVERY 48 HRS AND URINE SAMPLE WILL BE INFLUENCE BY MANY FACTORS, SUCH AS DRINKS TOO MUCH WATER. A FALSE NEGATIVE RESULT MAY OCCUR WHEN THE LEVELS OF HCG ARE BELOW THE SENSITIVITY LEVEL OF THE TEST AT THAT TIME. CONCLUSION: THE RETENTION STRIPS MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED. MFG 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

    TWO FALSE NEGATIVES ON MCKESSON PREG TESTS - WHEN SAMPLE SENT TO THE LAB, THE PT ACTUALLY WAS PREG. LOT # HCG8060144.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON MEDI-LAB HCG URINE CASSETTE HCG PREGNANCY TEST JHI INNOVACON, INC. FHC-102-KMK25 HCG8060144

    Patients

    Seq Age Sex Outcome Treatment
    1