BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 4821489 · Received June 5, 2015

    Report

    Report Number
    2245578-2015-00029
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 06/29/2015. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.00 ON A (B)(6) MALE PATIENT PRESENTED IN THE ED ON (B)(6) 2015 WITH SHORTNESS OF BREATH AND SWELLING IN BOTH LEGS. DATE: (B)(6) 2015, METHOD: N/A, RESULT: N/A, TIME: N/A, RESULT: A, SAMPLE COMMENTS: SAMPLE TIME: 0230; (B)(6) 2015, I-STAT, 0232, 0.06, A, SAME SAMPLE FROM ORIGINAL TUBE; (B)(6) 2015, I-STAT, 0242, 0.00, A, SAME SAMPLE FROM ORIGINAL TUBE; (B)(6) 2015, I-STAT, 0253, 0.09, A, SAME SAMPLE FROM ORIGINAL TUBE; (B)(6) 2015, I-STAT, 0321, 0.08, A, SAME SAMPLE FROM ORIGINAL TUBE, ALMOST 1 HR OLD (CUSTOMER AWARE). DUE TO PATIENT'S DETERIORATING CONDITION, THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE (B)(6) FOR TREATMENT. I-STAT TROPONIN RESULTS WERE IGNORED, AS STAFF WAS ATTEMPTING TO STABILIZE THE PATIENT. THE PATIENT WAS NOT TREATED ON THE TROPONIN RESULTS. BY THE TIME THE PATIENT REACHED THE HIGHER LEVEL OF CARE, THE PATIENT HAD BEEN INTUBATED. THE CUSTOMER REPORTS THAT CK-MB, BNP AND MYOGLOBIN TESTING WAS PERFORMED AT THE HIGHER LEVEL OF CARE ON A LAB ANALYZER, ALL WERE ALL ELEVATED. NO TROPONIN TESTING WAS CONDUCTED AT THE (B)(6). THE PATIENT WAS DIAGNOSED WITH SEPTICEMIA (SEPTIC SHOCK). PATIENT WAS ADMITTED TO THE ICU AND PASSED ON (B)(6) 2015. THE CUSTOMER REPORTS THAT THE CAUSE OF DEATH WAS ACUTE RENAL FAILURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. BASED ON THE INFORMATION PROVIDED BY THE FACILITY THERE IS NO INDICATION THAT THE I-STAT RESULTS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE INVESTIGATION IS UNDERWAY. CUSTOMER IS RETURNING PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363843 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA N15093

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR