BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CHEM8+ CONTROL, LEVEL 3

    MDR report key: 1012368 · Received March 11, 2008

    Report

    Report Number
    2245578-2008-00007
    Event Type
    Other
    Date Received
    March 11, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION AND RESOLUTION DETERMINED ON THE PHONE WITH ABBOTT POINT OF CARE TECH SUPPORT SPECIALIST AND THE CUSTOMER. MATERIAL WAS NOT RETURNED BY THE CUSTOMER. THE CAUSE OF THE INJURY WAS NOT DUE TO A PRODUCT MALFUNCTION BUT RATHER, THE CUSTOMER'S FAILURE TO FOLLOW PRODUCT LITERATURE. THE CUSTOMER WAS REFERRED TO AND ADVISED TO USE THE PRODUCT LITERATURE.

    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 3 THE CUSTOMER CUT THEIR FINGER. AS A RESULT, THIS PERSON WAS GIVEN A TETANUS BOOSTER INOCULATION. THERE WAS NO INDICATION THAT THERE WAS A PRODUCT MALFUNCTION. THE CUSTOMER INFORMED APOC THEY HAD FAILED TO FOLLOW INSTRUCTIONS FOR USE. THE I-STAT, CHEM8+ CONTROL, LEVEL 3 - A BUFFERED AQUEOUS SOLUTION FOR IN VITRO USE FOR QUALITY CONTROL ON THE I-STAT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CONTROL, LEVEL 3 IVD JJE ABBOTT POINT OF CARE INC. B06326

    Patients

    Seq Age Sex Outcome Treatment
    1