BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1935348 · Received December 16, 2010

    Report

    Report Number
    2183996-2010-02630
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 9, 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
    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 HER DIABETES SPECIALIST IS THE ONLY WHO PROGRAMS THE INFUSION DEVICE. PATIENT IS BLIND. PATIENT STATED AROUND THE BEGINNING OF (B)(6) 2010, THE DIABETES SPECIALIST PROGRAMMED THE BASAL RATE INTO THE INFUSION DEVICE. PATIENT REPORTED IN THE FIRST FEW DAYS HER BLOOD GLUCOSE LEVEL WAS OKAY, BUT THE LEVEL BEGAN BEING ELEVATED OFTEN. PATIENT STATED THE HIGHEST BLOOD GLUCOSE LEVEL SHE HAD WAS 480 MG/DL, SHE TOOK CORRECTION VIA THE INFUSION DEVICE BUT WITHOUT SUCCESS. PATIENT REPORTED SHE SOMETIMES CANNOT HEAR THE INFUSION DEVICE DELIVER THE BOLUS. PATIENT STATED SHE TRIED TO SOLVE THE PROBLEM BY CHANGING THE ACCESSORIES BUT THAT DID NOT HELP. PATIENT REPORTED HER DOCTOR CHECKED THE BASAL RATE AND NOTICED THAT THE RATE WAS INCORRECT OR LOST. PATIENT STATED HE PROGRAMMED THE BASAL RATE AGAIN AND ONCE AGAIN FOR A FEW DAYS HER BLOOD GLUCOSE LEVEL WAS OKAY. PATIENT REPORTED THAT ON THE WEEKEND OF (B)(6) 2010 HER BLOOD GLUCOSE BECAME ELEVATED AGAIN. PATIENT STATED THE DIABETES SPECIALIST CHECKED THE BASAL RATE AND THE BASAL RATE WAS CORRECTLY PROGRAMMED. PATIENT REPORTED THE DIABETES SPECIALIST WAS UNABLE TO SELECT THE TIME OR THE BOLUS, SO HE GAVE HER A DIFFERENT INFUSION DEVICE AND NOW HER BLOOD GLUCOSE LEVEL IS OKAY. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. 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 46 YR Required Intervention INSULIN INFUSION SET| INSULIN