BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2181846 · Received July 28, 2011

    Report

    Report Number
    1823260-2011-04047
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED INFORM SYSTEM PATIENT BLOOD GLUCOSE RESULTS: (B)(6) 4:54 PM INFORM RESULT HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL; 4:55 PM INFORM RESULT HI; 4:56 PM INFORM RESULT HI; 5:00 PM LAB RESULT 149 MG/DL; 6:08 INFORM RESULT HI; 6:15 LAB RESULT 172 MG/DL; (B)(6) 2011 7:44 AM INFORM RESULT 395 MG/DL; 7:44 AM INFORM RESULT 124 MG/DL; 9:22 PM INFORM RESULT 588 MG/DL. 9:24 PM INFORM RESULT 318 MG/DL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE METER AND 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 551466

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR COUMADIN| OXYCONTIN 2XDAY| PREVENTIL ALBUTEROL| DULCOLAX SUPPOSITORY| CHRONULAC 3XDAY| PREDNISONE| LANTUS| ATROVENT NUBULIZER 4XDAY| PROTONIX 1XDAY| NOVOLOG 3XDAY| METFORMIN| COLACE| ZOFRIN 4XDAY| LASIX 2XDAY| "NS INFUSION" 1XDAY| FLEET ENEMA