BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1140083 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06487
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT NURSES MISINTERPRETED THE INFORM SYSTEM'S ERROR 83 AS A LOW RESULT, TREATED PT WITH DEXTROSE, LAB RESULT WAS 1000 MG/DL. CALLER REPORTED THAT HE RAN AN ADDITIONAL INFORM SYSTEM BLOOD GLUCOSE TEST USING THE SAME LAB SAMPLE AND GOT A RESULT OF HI, WHICH ON THE INFORM SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL. CALLER REPORTED THAT THE PT HAD SYMPTOMS OF HYPERGLYCEMIA AND WAS IN A STATE OF DIABETIC KETOACIDOSIS. MFR'S LABELING LIST DIABETIC KETOACIDOSIS AS A LIMITATION OF THE SYSTEM. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 550531

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention