BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2173418 · Received July 23, 2011

    Report

    Report Number
    1823260-2011-03918
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 25, 2011
    Report Date
    August 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM BLOOD GLUCOSE RESULTS FOR PATIENT 1: (B)(6) 2011 AT 02:18 AM INFORM SYSTEM 1 WAS 27 MG/DL; (B)(6) 2011 AT 02:21 AM INFORM SYSTEM 1 WAS 111 MG/DL. NO ADVERSE EVENT REPORTED. (B)(6) 2011 AT 06:02 AM, INFORM SYSTEM 1 WAS 340 MG/DL; (B)(6) 2011 AT 06:04 AM, INFORM SYSTEM 2 WAS 125 MG/DL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    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 551514

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR