BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2220326 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04464
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER RECEIVED A RESULT OF 52 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 68 MG/DL ON AN PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT THE CUSTOMER WAS TREATED WITH ORANGE JUICE PRIOR TO THE 52 MG/DL RESULT AND SHE WAS GIVEN MORE ORANGE JUICE, PEANUT BUTTER AND A BOWL OF OATMEAL WITH BANANA IN IT AFTER THE 68 MG/DL RESULT. 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 THE CUSTOMER RAN OUT OF THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 551447

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR ADALAT| ALTACE| LANTUS| HUMALOG (DAILY)| CLONIDINE