BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2072985 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01186
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 31, 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 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

    PATIENT REPORTED THAT THE INSULIN DELIVERY OF THE INFUSION DEVICE WAS TOO LOW, AND THIS CAUSED ONGOING ELEVATED BLOOD GLUCOSE OF ABOVE 30 MMOL/L (540 MG/DL). NORMAL BLOOD GLUCOSE IS 6-7 MMOL/L (108-126 MG/DL). THIS FIRST BEGAN 2 WEEKS PRIOR TO THE REPORT. PATIENT CHANGED THE ACCESSORIES AND DELIVERED INSULIN THROUGH THE INFUSION DEVICE, BUT THIS WAS NOT SUCCESSFUL IN LOWERING BLOOD GLUCOSE. PATIENT SWITCHED TO A BACKUP INFUSION DEVICE, AND BLOOD GLUCOSE WAS THEN "OKAY." PATIENT DID NOT HAVE AN INFECTION OR A CHANGE TO MEDICATIONS. INFUSION DEVICE WAS EXPOSED TO ELECTROMAGNETIC FIELDS WHEN PATIENT WAS AT THE DENTIST IN (B)(6) 2011. INFUSION DEVICE WAS NOT EXPOSED TO WATER. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT 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 7 YR INSULIN| INSULIN INFUSION SET