BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2253052 · Received August 31, 2011

    Report

    Report Number
    2245578-2011-00171
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 15, 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, AND #2245578-2011-00171 THROUGH 2245578-2011-00183 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 0.12 NG/ML ON A PATIENT. RESULTS (NG/ML): (B)(6) 2011 22:35 COLLECTION; (B)(6) 2011 22:42 TESTING WITH RESULT OF <0.01; (B)(6) 2011 00:00 90 MINUTE COLLECTION; (B)(6) 2011 00:23 90 MINUTE TESTING WITH RESULT OF 0.12; (B)(6) 2011 00:48 90 MINUTE REPEAT TESTING, RESULT OF <0.01. NO TESTING PERFORMED IN THE LAB. 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 52 YR