BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 9237810 · Received October 25, 2019

    Report

    Report Number
    2245578-2019-00255
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 25, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    NA
    Removal / Correction Number
    APOC2019-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. APOC PRODUCT ACTION NUMBER: (B)(4). PRODUCT NAME: I-STAT CTNI (BLUE) CARTRIDGES, LIST NUMBER: 06P23-25, UDI: (B)(4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN COMPLETED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. THE I-STAT CTNI TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF CARDIAC TROPONIN I (CTNI) IN WHOLE BLOOD OR PLASMA SAMPLES. MEASUREMENTS OF CARDIAC TROPONIN I ARE USED IN THE DIAGNOSIS AND TREATMENT OF MYOCARDIAL INFARCTION AND AS AN AID IN THE RISK STRATIFICATION OF PATIENTS WITH ACUTE CORONARY SYNDROMES WITH RESPECT TO THEIR RELATIVE RISK OF MORTALITY. THE I-STAT SYSTEM AUTOMATICALLY RUNS A COMPREHENSIVE SET OF QUALITY CHECKS OF BOTH THE ANALYZER AND CARTRIDGE PERFORMANCE EACH TIME A SAMPLE IS TESTED. THIS INTERNAL QUALITY SYSTEM WILL SUPPRESS RESULTS BY GENERATING A QUALITY CHECK CODE (QCC) IF THE ANALYZER, CARTRIDGE OR SAMPLE DOES NOT MEET CERTAIN INTERNAL SPECIFICATIONS. IT IS TYPICAL FOR THE SYSTEM TO SUPPRESS A VERY SMALL PERCENTAGE OF RESULTS DURING NORMAL OPERATION GIVEN THE STRINGENCY OF THESE SPECIFICATIONS. WHEN A QCC OCCURS, A SINGLE CODE NUMBER, THE TYPE OF PROBLEM AND THE NEXT STEP TO BE TAKEN WILL BE DISPLAYED ON THE I-STAT ANALYZER. THROUGH A COMBINATION OF INTERNAL STUDIES AND CUSTOMER REPORTS, ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT I-STAT CTNI BLUE CARTRIDGES MAY GENERATE A HIGHER THAN EXPECTED NUMBER OF QCCS. THE OBSERVED RATE OF QCCS COULD BE IN THE 3 TO 5% RANGE. THERE IS A POTENTIAL TO DELAY THE GENERATION OF PATIENT RESULTS FOR TROPONIN I IF CARTRIDGES GENERATE A QUALITY CHECK CODE. ABBOTT POINT OF CARE HAS MADE THE DECISION TO COMMUNICATE THIS INFORMATION TO THE POTENTIALLY IMPACTED U.S. CUSTOMERS. ABBOTT POINT OF CARE HAS NOT RECEIVED ANY REPORTS OF PATIENT HARM ASSOCIATED WITH THIS ISSUE. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. THERE HAVE NOT BEEN ANY INJURIES ASSOCIATED WITH THIS ISSUE. THERE HAS NOT BEEN ANY ADVERSE EVENT OR ADVERSE REACTION REPORTS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037190 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE, MMI ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1