BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CHEM8 LEVEL 1 CONTROL

    MDR report key: 1277432 · Received October 31, 2008

    Report

    Report Number
    2245578-2008-00077
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2008, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT WHILE OPENING AN I-STAT CHEM8+ CONTROL, LEVEL 1, THE CUSTOMER CUT THEIR FINGER. THERE WAS NO MEDICAL TREATMENT GIVEN AS A RESULT OF THE CUSTOMER CUTTING THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8 LEVEL 1 CONTROL IVD JJE ABBOTT POINT OF CARE INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1