BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1854553 · Received October 5, 2010

    Report

    Report Number
    1823260-2010-05908
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 26, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A PATIENT RECEIVED THE RESULTS OF 566 MG/DL AND 54 ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITHIN 10 MINUTES OF ANOTHER RESULT OF 60 MG/DL OBTAINED ON INFORM SYSTEM 2. REPORTER STATED THAT THE PATIENT WAS TREATED WITH FOUR GLUCOSE TABLETS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THERE WERE NOT ANY STRIPS LEFT, THEREFORE NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT SIDE RAIL HAS EXCESSIVE MOVEMENT AND THE LEFT SIDE RAIL IS BROKEN. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 551260

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR