BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2141020 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01617
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. RECENTLY, PT CHANGED THE CARTRIDGE AND THE INFUSION DEVICE DISPLAYED AN E10 CARTRIDGE ERROR. AT 4 PM, BLOOD GLUCOSE WAS 125 MG/DL. PT ATE 3 BE AND DELIVERED 4-5 IE VIA THE INFUSION DEVICE. AT 7:30 PM, BLOOD GLUCOSE WAS 536 MG/DL. PT DELIVERED 12 IE AND THEN 6 IE VIA THE INFUSION DEVICE. AT 8:30 PM, BLOOD GLUCOSE WAS 295 MG/DL. PT CHANGES THE INFUSION NEEDLE EVERY 3 DAYS AND THE TUBE EVERY 5-6 DAYS. PT WAS REFERRED TO THE USER GUIDE. INFUSION DEVICE WAS NOT EXPOSED TO WATER. INFUSION DEVICE WAS EXPOSED TO X-RAY DURING A SCAN OF HIS SPINAL COLUMN. PT HAD A COLD AND STOMACH-ACHE AND RECENTLY STARTED ANTIBIOTICS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR INSULIN INFUSION SET| INSULIN