BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2143319 · Received June 29, 2011

    Report

    Report Number
    1823260-2011-03508
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT RECEIVED THE RESULTS OF 31 MG/DL, 591 MG/DL AND 30 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE INFORM SYSTEM. REPORTER STATES THAT THE PATIENT WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AND WAS TREATED WITH 1 AMPOULE OF DEXTROSE. NO OTHER 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 551446

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR POTASSIUM (DAILY)| PRINIVIL (DAILY)| AVELOX (TWICE DAILY)| INSULIN (DAILY)| "FARASULPHATE" (DAILY)| VITAMIN C (TWICE DAILY)| ZINC SULFATE (DAILY)| DIFLUCAN (DAILY)| GLYBURIDE (TWICE DAILY)| PROTONIX (TWICE DAILY)| HYDROCHLOROTHIAZIDE (DAILY)