BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICON 25 HCG

    MDR report key: 524450 · Received February 13, 2004

    Report

    Report Number
    2916283-2004-00001
    Event Type
    Other
    Date Received
    February 13, 2004
    Date of Event
    January 15, 2004
    Report Date
    February 13, 2004
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHJ
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT AN EMERGENCY ROOM (ER) PT HAD A URINE SAMPLE TESTED WITH AN ICON 25 HCG TEST KIT AND THE HCG RESULT WAS NEGATIVE (-). THE ER PHYSICIAN DID NOT BELIEVE THE NEGATIVE URINE TEST RESULT AND REQUESTED A SERUM SAMPLE TO BE TESTED QUANTITATIVELY FOR HCG. THE CUSTOMER INDICATED THAT THE PHYSICIAN DID NOT PROVIDE A SPECIFIC REASON AS TO WHY THE ICON 25 HCG RESULT WAS NOT ACCEPTED. THE PT'S SERUM SAMPLE WAS SENT TO THE LAB FOR A SERUM QUANTITATIVE BHCG. THE QUANTITATIVE BHCG RESULT WAS 150 MIU/ML. THERE HAS BEEN NO CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON 25 HCG QUALITATIVE HCG TEST JHJ BECKMAN COULTER INC. NA HCG030802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other