BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2781861 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01496
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT CHANGED HER INSULIN CARTRIDGE AND INFUSION SET BEFORE BED AND AT THAT TIME HER BLOOD GLUCOSE LEVEL WAS 146 MG/DL. WHEN SHE WOKE UP ON (B)(6) 2012, HER BLOOD GLUCOSE LEVEL ELEVATED. SHE WENT TO HER DIABETIC SPECIALIST AND HER BLOOD GLUCOSE LEVEL WAS 511 MG/DL AND KETON++. THE DIABETIC COUNSELOR CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND SHE NOTICED BLOOD IN THE USED INFUSION SET. THE PT'S ELEVATED BLOOD GLUCOSE LEVEL WAS CORRECTED WITH AN INSULIN INJECTION. THE PT'S BLOOD GLUCOSE LEVEL LOWERED TO 300 MG/DL AND KETON 0. THE PT HAS PROBLEMS WITH CIRCULATION AND WENT TO THE HOSPITAL BECAUSE OF THIS PROBLEM. WHILE AT THE HOSPITAL THEY DETECTED BLOOD IN THE INFUSION SET. THE DIABETIC COUNSELOR AND THE DOCTOR THINK THE INFUSION DEVICE DOES NOT DELIVER INSULIN WITH ENOUGH PRESSURE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR ACCESSORIES| INSULIN INFUSION PUMP| INSULIN