BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2317850 · Received October 14, 2011

    Report

    Report Number
    2245578-2011-00265
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    July 11, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ON A PT IN THE ED. I-STAT: DATE: (B)(6) 2011, 16:16, RESULT: 0.08 NG/ML. DATE: (B)(6) 2011, 16:18, RESULT: 0.08 NG/ML, DATE: (B)(6) 2011, 16:34, RESULT: 0.10 NG/ML. (B)(6) (LAB): DATE: (B)(6) 2011, 15:48, RESULT: <0.01 NG/ML. THE SUSPECTED DISCREPANT RESULTS WERE NOT RELEASED TO A PHYSICIAN OR CAREGIVER. BASED ON THE INFO 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 T11096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK