BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1902580 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06821
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 14, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE POD "QUIT WORKING WITHOUT ANY ALARMS" FROM THE PDM. AS A RESULT, THE CUSTOMER WENT INTO DKA AND WAS ADMITTED TO THE HOSPITAL IN "CRITICAL CONDITION" WITH A BG READING OF 739 MG/DL. THE CUSTOMER STATED HE COULD HAVE LOST HIS LIFE "DUE TO A MALFUNCTION" OF THE POD, THOUGH NO SPECIFIC FAILURE MODE WAS REPORTED. IT IS UNK WHAT PRODUCT ISSUES WERE ENCOUNTERED WHILE HE WAS WEARING THE DEVICE. HE SAID THE PDM INDICATED THAT THE POD "WAS STILL WORKING CORRECTLY," SO HE CONTINUED ADMINISTERING CORRECTION BOLUSES, "WHICH NEVER WORKED." THE CUSTOMER REPORTEDLY "VOMITED AND WAS DEATHLY ILL FOR TWO DAYS" BEFORE BEING TAKEN TO THE EMERGENCY ROOM; HE ADMITTED IN THE ICU FOR THREE DAYS. THE POD WILL NOT BE RETURNED FOR EVALUATION. NOTE: IN ORDER TO GAIN A BETTER UNDERSTANDING OF WHAT MAY HAVE OCCURRED, INSULET CUSTOMER SUPPORT HAD ATTEMPTED TO CONTACT THE CUSTOMER FOR INFORMATION RELATED TO THE PDM INVOLVED WITH THIS EVENT. THIS INFORMATION COULD NOT BE OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 200S-RANGE MG/DL AND 94 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 551302

    Patients

    Seq Age Sex Outcome Treatment
    1 090 YR BLOOD PRESSURE MONITOR| GLIMEPIRIDE