BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-SAT CTNI CARTRIDGE

    MDR report key: 802692 · Received January 8, 2007

    Report

    Report Number
    2245578-2007-00001
    Event Type
    Other
    Date Received
    January 8, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 8, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE AND TEST INFORMATION SHEET FOR CARDIAC TROPONIN I/ (CTNI) IN THE I-STAT SYSTEM MANUAL STATES THE 0 TO 99% RANGE OF RESULTS IN A NORMAL, HEALTHY POPULATION WAS 0.0NG/ML TO 0.08NG/ML. SINCE CTNI IS NOT GENERALLY DETECTED IN THE BLOOD OF HEALTHY PERSONS, ANY LEVEL OF CTNI ABOVE THE UPPER LIMIT OF THE REFERENCE RANGE DEFINED IN A HEALTHY POPULATION SHOULD BE CONSIDERED INDICATIVE OF MYOCARDIAL NECROSIS. IN THIS CASE, THE CTNI RESULT OF THE PT WAS 0.17NG/ML, ABOVE THE UPPER LIMIT OF THE REFERENCE RANGE (0.08NG/ML).

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A PT'S TREATMENT WAS CHANGED BASED ON I-STAT CARDIAC TROPONIN I RESULT OF 0.17NG/ML. A RENAL DIALYSIS PATIENT WAS BROUGHT TO THE EMERGENCY DEPT VIA EMS. PATIENT WAS TREATED FOR CHEST PAIN WITH MEDICATIONS INCLUDING A NITROGLYCERIN DRIP. NITRO DRIP WAS DISCONTINUED BASED ON A PAIN SCALE OF ZERO AND A MISINTERPRETATION OF THE CARDIAC TROPONIN I RESULT AS NEGATIVE. PT'S CHEST PAIN RETURNED IN APPROXIMATELY 90 MINUTES. PATIENT WAS ADMITTED TO CCU WITH DIAGNOSIS OF CHEST PAIN AND NSTEMI. THE CARTRIDGE AND TEST INFO SHEET FOR CARDIAC TROPONIN I/(CTNI) IN THE I-STAT SYSTEM MANUAL STATES THE 0 TO 99% RANGE OF RESULTS IN A NORMAL, HEALTHY POPULATION WAS 0.0NG/ML TO 0.08NG/ML. SINCE CTNI IS NOT GENERALLY DETECTED IN THE BLOOD OF HEALTHY PERSONS, ANY LEVEL OF CTNI ABOVE THE UPPER LIMIT OF THE REFERENCE RANGE DEFINED IN A HEALTHY POPULATION SHOULD BE CONSIDERED INDICATIVE OF MYOCARDIAL NECROSIS. IN THIS CASE, THE CTNI RESULT OF THE PT WAS 0.17NG/ML, ABOVE THE UPPER LIMIT OF THE REFERENCE RANGE (0.08NG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-SAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA U06299A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other