BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1963043 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00266
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 2, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(6).

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A PATIENT RECEIVED THE RESULT OF 70 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 183 MG/DL OBTAINED ON INFORM SYSTEM 2. REPORTER ALSO ALLEGED THAT A FEW HOURS LATER, THE PATIENT RECEIVED THE RESULT OF 454 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 91 MG/DL OBTAINED ON INFORM SYSTEM 2. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 NA 551304

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR UNKNOWN MEDICATION (SLIDING SCALE)| LANTUS (NIGHTLY)