BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3223929 · Received July 12, 2013

    Report

    Report Number
    2245578-2013-00079
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/24/2013. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT (B)(4) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.49 ON A PATIENT. ABBOTT POINT OF CARE (APOC) WAS CONTACTED ON (B)(6) 2013 OF THE COMPLAINT REGARDING THE EVENT. THERE WAS NO PATIENT AVAILABLE AT THE TIME OF THIS REPORT. TEST DATE: (B)(6) 2013 DATE SAMPLE TIME I-STAT APEX (LAB), (B)(6) 2013 A 23.32 0.49 <0.04; (B)(6) 2013 A 00.13 0.00 <0.04. THERE WERE NO INJURIES REPORTED WITH THIS EVENT. APOC HAS DETERMINED THAT A POTENTIAL MALFUNCTION EXISTS BASED ON THE TEST TIMES PROVIDED ALTHOUGH NOT CONFIRMED AT THIS TIME, PENDING PRODUCT INVESTIGATION. THE TIME OF FORTY ONE MINUTES BETWEEN RESULTS SUGGESTS THAT THE PRODUCT IS POTENTIALLY OUTSIDE OF THE TYPICAL PERFORMANCE OF THE ASSAY. APOC HAS REQUESTED PATIENT INFORMATION. CARTRIDGE LOT INFORMATION WAS RECEIVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322121 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA U13019

    Patients

    Seq Age Sex Outcome Treatment
    1