BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052290 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04285
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS A PT LAB RESULT FROM A SAMPLE DRAWN AT 15:00 WAS 25 MG/DL, INFORM SYSTEM RESULT AT 15:11 WAS 197 MG/DL. CUSTOMER REPORTS THAT THE INFORM SYSTEM HAD PASSED LEVELS 1 AND 2 CONTROLS AT 00:16 AND 00:18, RESPECTIVELY. CUSTOMER REPORTED NO PATIENT SYMPTOMS, PROVIDED NO TREATMENT INFORMATION. NO ADVERSE EVENT REPORTED. 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 549916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK