BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2172042 · Received July 15, 2011

    Report

    Report Number
    2183996-2011-02047
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 30, 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
    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'S WIFE REPORTED SHE THINKS THE INFUSION SETS AND THE INFUSION DEVICE WAS ALSO THE REASON FOR THE SICKNESS AND DEATH OF HER HUSBAND. WIFE STATED THE PATIENT USED A COMPETITOR'S INFUSION DEVICE FOR 4 YEARS AND HIS BLOOD GLUCOSE LEVEL WAS OFTEN TOO HIGH. WIFE REPORTED THE PATIENT EXPERIENCED OTHER MEDICAL CONCERNS AS WELL. THE PATIENT'S DIET COUNSELOR REPORTED THE COMPETITOR'S INFUSION DEVICE WAS TOO COMPLICATED FOR THE PATIENT AND SHE CHANGED HIM TO A DIFFERENT INFUSION DEVICE AND INFUSION SETS. DIET COUNSELOR STATED THE PATIENT ALSO HAD PROBLEMS WITH THIS INFUSION DEVICE AND A LOT OF PROBLEMS WITH THE INFUSION SETS. DIET COUNSELOR REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL RANGED FROM 400 MG/DL TO 'HI'. PATIENT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. DIET COUNSELOR STATED THE PATIENT TOOK CORRECTION VIA PEN. DIET COUNSELOR REPORTED THE PATIENT USED THE INFUSION DEVICE FOR 8 WEEKS AND THEN HE CHANGED TO HIS OLD INFUSION DEVICE. DIET COUNSELOR STATED THE PATIENT'S BLOOD GLUCOSE LEVEL WAS BETTER BUT NOT OKAY. ON (B)(6) 2011, DIET COUNSELOR REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A THROMBOSIS AND PERIPHERAL ARTERY OCCLUSIVE DISEASE IN HIS LEG. DIET COUNSELOR STATED THE PATIENT WAS CHANGED FROM PUMP THERAPY TO ICT (INTENSIFIED CONVENTIONAL INSULIN THERAPY) WHILE IN THE HOSPITAL. PATIENT DIED ON (B)(6) 2011. NO FURTHER INFORMATION IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE 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 76 YR Death INSULIN: DATE OF TX: (B)(6)| INSULIN INFUSION SET: TX DATE: (B)(6)