BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRITECH ICON II HCG

    MDR report key: 269432 · Received March 9, 2000

    Report

    Report Number
    269432
    Event Type
    Malfunction
    Date Received
    March 9, 2000
    Date of Event
    December 6, 1999
    Report Date
    March 8, 2000
    Manufacturer
    HYBRITECH CORP.
    Product Code
    LCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREGNANCY TEST KIT GIVING ALL POSITIVE RESULTS. AFTER LAB MGR CALLED THE CO, THERE WAS A POSSIBILITY THAT THE REAGENTS WERE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRITECH ICON II HCG PREGNANCY TEST KIT LCY HYBRITECH CORP. * 990603
    2 HYBRITECH ICON II HCG REAGENT A LCY HYBRITECH CORP. * 960455
    3 HYBRITECH ICON II HCG REAGENT B LCY HYBRITECH CORP. * 960460A
    4 HYBRITECH ICON II HCG REAGENT C LCY HYBRITECH CORP. * 960611
    5 HYBRITECH ICON II HCG DILUENT LCY HYBRITECH CORP. * 960459
    6 HYBRITECH ICON II HCG CYLINDERS LCY HYBRITECH CORP. * 960469C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA