BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2965964 · Received February 16, 2013

    Report

    Report Number
    2245578-2013-00009
    Event Type
    Malfunction
    Date Received
    February 16, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Removal / Correction Number
    APOC2012-007
    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. (B)(4). PRODUCT NAME: LIST#: LOT #: BOX NUMBER(S): I-STAT CTNI CARTRIDGE, 03P90-25, P12179, 0171 TO 0192. ALSO REFERENCE: DEPARTMENT OF HEALTH AND HUMAN SERVICES LETTER DATED: JANUARY 30, 2013 RE: RECALL NO. Z-0716-2013.

    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. ABBOTT POINT OF CARE INC. (APOC) DETERMINED THAT 10 BOXES OF I-STAT CTNI CARTRIDGES FROM LOT P12179 HAVE AN INCORRECT BARCODE APPLIED TO THE CARTRIDGE PORTION PACK (BOXES 0171 TO 0192; TOTAL OF 250 CARTRIDGES). ATTEMPTING TO RUN CARTRIDGES FROM THE AFFECTED BOXES, AFTER SCANNING THE BARCODE, WILL PRODUCE A QC CODE 15. NO RESULT WILL BE REPORTED. ALL OTHER CTNI BOXES AND LOTS ARE UNAFFECTED BY THIS ISSUE. ALL UNUSED CARTRIDGES (FROM BOXES 171 TO 0192 OF LOT P12179) WERE REPLACED OR CREDITED AND WILL BE DESTROYED AS PER LOCAL REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69731 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA P12179

    Patients

    Seq Age Sex Outcome Treatment
    1