BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 883692 · Received July 20, 2007

    Report

    Report Number
    2245578-2007-00015
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 22, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A PATIENT'S TREATMENT WAS DELAYED BECAUSE AN I-STAT CARDIAC TROPONIN I CARTRIDGE GENERATED AN ERROR CODE. THE SAMPLE WAS REPEATED AND ANOTHER ERROR CODE WAS OBSERVED. A SAMPLE WAS THEN SENT TO REFERENCE LAB AT 7:35 ON THE SAME DAY. THE REFERENCE LAB REPORTED A RESULT OF 0.3 NG/ML AT 11:00 ON THE SAME DAY. A REFERENCE RANGE OF 0.0 TO 0.04 NG/ML WAS PROVIDED. COMPLAINANT DID NOT INDICATE THAT PATIENT OUTCOME WAS NEGATIVELY IMPACTED BY THE DELAY IN DELIVERING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA U07033A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other