BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2142446 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01889
    Event Type
    Death
    Date Received
    June 22, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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

    DAUGHTER REPORTED THAT PATIENT DIED ON (B)(6) 2011 WHILE USING THE INFUSION DEVICE. PATIENT LIVED BY HIMSELF AND THE LAST TIME HE MEASURED HIS BLOOD GLUCOSE WAS AT 3:00 A.M. ON (B)(6) 2011. HE WAS AT HIS PHYSICIAN'S OFFICE THE DAY BEFORE HIS DEATH AND ALSO HAD AN APPOINTMENT SCHEDULED ON (B)(6) 2011. PHYSICIAN TOLD A COMPANY REPRESENTATIVE THAT PATIENT HAD BEEN ASKED SEVERAL TIMES TO DECREASE THE INSULIN DOSAGE DUE TO MANY HYPOGLYCEMIC EVENTS. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS 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 63 YR Death INSULIN INFUSION SET| INSULIN