BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3081132 · Received April 26, 2013

    Report

    Report Number
    2245578-2013-00065
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NA.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.45 ON A MALE PATIENT THAT CAME TO E.R. COMPLAINING OF DIZZINESS, HEAVY BREATHING. PATIENT HAD A PRIOR HISTORY OF HEART ATTACK, STROKE AND ANEURYSM. THERE WAS NO REPEAT TEST ON I-STAT AND THERE WERE NO OTHER TESTS PERFORMED ON THE PATIENT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME.METHOD TIME RESULT SAMPLE TIMEI-STAT 08:00PM 0.45 (POS) UNKVISTA 08:30PM 0.057 (NEG) 07:40PMVISTA 11:00PM 0.059 (NEG) UNKTHE CUSTOMER STATES THAT THE PATIENT WAS TREATED BASED ON I-STAT TROPONIN RESULT AND EKG RESULT. THE PATIENT WAS GIVEN A DOSE OF HEPARIN AND THEN ADMINISTERED A SECOND DOSE OF HEPARIN BY "ACCIDENT." THE CUSTOMER CONFIRMED THE SECOND DOSE WAS A HOSPITAL ERROR. THE PATIENT THEN COMPLAINED OF HEADACHE AND AN MRI WAS UNDERTAKEN WHICH IDENTIFIED CEREBRAL BLEEDING. THE PHYSICIAN STATES THAT THE PATIENT MIGHT HAVE HAD CEREBRAL BLEEDING BEFORE THE HEPARIN DOSE WAS GIVEN AS THE HEPARIN DOSE ALONE WOULD NOT CAUSE THE CEREBRAL BLEEDING TO THE EXTENT THEY OBSERVED. THE CUSTOMER STATES THAT THE PATIENT WAS STILL IN CARE AS OF (B)(6) 2013. AT THIS TIME THERE IS NO REASON TO BELIEVE THAT A MALFUNCTION EXISTS BASED ON THE INFORMATION AVAILABLE. APOC BELIEVES THAT PATIENT CARE WAS IMPACTED AND AN ADVERSE EVENT OCCURRED. HOWEVER, IT IS NOT CLEAR WHETHER I-STAT CAUSED OR CONTRIBUTED TO THE EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183068 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA U12329

    Patients

    Seq Age Sex Outcome Treatment
    1 Other