BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1905750 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-02350
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 IN THE PAST 3 WEEKS, HER BLOOD GLUCOSE VALUE HAS BEEN ELEVATED AND UNSTABLE. PATIENT STATED THE BLOOD GLUCOSE VALUES HAVE BEEN ABOUT 450 MG/DL. PATIENT'S USUAL BLOOD GLUCOSE VALUE IS ABOUT 110-130 MG/DL. PATIENT REPORTED SHE ATTEMPTED TO CORRECT THE ELEVATED BLOOD GLUCOSE BY BOLUSING BUT THE ISSUE PERSISTED. PATIENT STATED THE INFUSION DEVICE HAS NOT GIVEN AN ALARM AND SEEMS TO WORK PROPERLY. PATIENT REPORTED SHE NOTICED THE ELEVATED BLOOD GLUCOSE LEVEL BECAUSE SHE HAD A STRONG HEADACHE. PATIENT STATED SHE SWITCHED TO HER OLD INFUSION DEVICE AND HER BLOOD GLUCOSE VALUE GOT BETTER AND RETURNED TO NORMAL. PATIENT'S NORMAL BLOOD GLUCOSE VALUE WAS NOT PROVIDED. PATIENT REPORTED SHE BELIEVES THE ISSUE IS DUE TO WRONG INSULIN DELIVERY. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 Required Intervention INSULIN| INSULIN INFUSION SET