BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INRCARTRIDGE

    MDR report key: 3473470 · Received November 18, 2013

    Report

    Report Number
    2245578-2013-00199
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 5, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Removal / Correction Number
    APOC2013-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS COMPLETED ON (B)(4) 2013 AND A DEFICIENCY WAS IDENTIFIED. APOC PRODUCT ACTION NUMBER: (B)(4). DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTS UNACCEPTABLE METHOD COMPARISON WITH I-STAT VS STAGO. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER REPORTS THAT THE PATIENTS ARE TREATED BASED ON THE LAB INSTRUMENTS RESULTS. DATE PT. I-STAT STAGO (LAB) (B)(6) 2013 28 4.4 2.90 (B)(6) 2013 29 6.9 5.05 (B)(6) 2013 34 5.9 4.08 (B)(6) 2013 35 5.2 3.86 (B)(6) 2013 36 7.3 4.88 (B)(6) 2013 42 7.3 6.53 (B)(6) 2013 43 7.7 5.40 (B)(6) 2013 45 5.3 3.44 (B)(6) 2013 46 6.9 4.29 (B)(6) 2013 47 >8.0 5.47 (B)(6) 2013 48 4.8 3.90 (B)(6) 2013 49 5.1 4.41 (B)(6) 2013 50 5.0 4.51 (B)(6) 2013 52 4.4 2.67 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
    597621 I-STAT PT/INRCARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA C13164A

    Patients

    Seq Age Sex Outcome Treatment
    1