BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2313399 · Received October 3, 2011

    Report

    Report Number
    2245578-2011-00217
    Event Type
    Malfunction
    Date Received
    October 3, 2011
    Date of Event
    September 4, 2011
    Report Date
    September 23, 2011
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    MMI
    Removal / Correction Number
    APOC2011-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT RESULT OF 0.12 NG/ML ON A PT. I-STAT RESULTS (NG/ML): ON (B)(6) 2011 11:57 INITIAL COLLECTION. ON (B)(6) 2011 11:56 INITIAL TESTING WITH RESULT OF <0.01. ON (B)(6) 2011 13:34 90 MINUTE COLLECTION. ON (B)(6) 2011 13:34 90 TESTING WITH RESULT OF 0.12. NO REPEAT TESTING PERFORMED ON THE I-STAT. LAB RESULT: <0.006 (CENTAUR). THE SUSPECTED DISCREPANT RESULTS WERE RELEASED TO A PHYSICIAN OR CAREGIVER. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE, INC. NA T11140

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR