BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT ISTAT

    MDR report key: 10194846 · Received June 24, 2020

    Report

    Report Number
    MW5095213
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 15, 2020
    Report Date
    June 22, 2020
    Manufacturer
    ABBOTT POINT OF CARE CANADA LIMITED
    Product Code
    CGL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    POC ISTAT RESULTS WERE INCORRECT. HIGHLY DEFECTIVE CR 5.1. RESULTS INDICATED SEVERE RENAL ISSUES. PT HAD NO PRIOR HISTORY OF RENAL IMPAIRMENT. COMPLETED MRI W/O CONTRAST DUE TO THIS RESULT. PT WENT TO (B)(6) ED FOR EVALUATION. LABS DRAWN THERE INDICATED NORMAL RENAL FUNCTION 0.9 CR. CONCERN FOR DEFECTIVE CARTRIDGE. DEVICE HAS FUNCTIONED W/O ISSUE SINCE EVENT. THE PT AND HER PHYSICIAN WERE MADE AWARE OF THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653421 ABBOTT ISTAT ELECTRODE, ION BASED, ENZYMATIC, CREATININE CGL ABBOTT POINT OF CARE CANADA LIMITED ISTAT 1 A20061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other