BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2249897 · Received September 2, 2011

    Report

    Report Number
    2245578-2011-00193
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR REPORTS # 2245578-2011-00162, # 2245578-2011-00171 THROUGH 2245577-2011-00183, 2245578-2011-00192 ARE FROM A SINGLE USER SITE. THE INTERNAL INVESTIGATION IS IN PROGRESS; NO OVERALL TRENDS HAVE BEEN IDENTIFIED IN PRODUCT LOT(S) USED. THE ISSUES APPEAR TO BE ISOLATED TO SPECIFIC SITES. THE SITE HAS INITIATED USE OF A TUBE ROCKING PLATFORM TO ENSURE THE BLOOD SAMPLE IS MIXED WELL (AS RECOMMENDED IN PRODUCT LABELING) WHICH THE SITE REPORTS HAS RESOLVED THE ISSUE.

    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 0.11 NG/ML ON A PATIENT. I-STAT RESULTS (NG/ML): (B)(6) 2011, 20:25, INITIAL COLLECTION. AUGUST 13, 2011, 20:54, INITIAL TESTING WITH RESULT OF 0.11. (B)(6) 2011, 22:42, 90 MINUTE COLLECTION. (B)(6) 2011, 23:19, 90 MINUTE TESTING WITH RESULT OF 0.02. LAB RESULT: 0.019. THE SUSPECTED DISCREPANT RESULTS WERE RELEASED TO THE 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 CANADA LTD. NA T11118A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR