BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890042 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02209
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT'S ROOMMATE REPORTED THE PT'S INFUSION DEVICE GAVE AN ERROR MESSAGE AND THEN STOPPED WORKING. ROOMMATE STATED THE INFUSION DEVICE STOPPED WORKING WHILE THE PT WAS ASLEEP. ROOMMATE REPORTED THE PT HAD TO BE TAKEN TO THE HOSPITAL BY HER NEIGHBOR. HAD ROOMMATE REVIEW INFUSION DEVICE FOR ALERT HISTORY. ROOMMATE STATED THE LAST ALERT MESSAGE IN THE INFUSION DEVICE'S MEMORY WAS AN A1 (CARTRIDGE LOW) ALERT THAT OCCURRED ON (B)(6) 2010. ROOMMATE REPORTED THE PT WAS TAKEN TO THE HOSPITAL IN (B)(6), 2010. ROOMMATE STATED THE PT COULD NOT WALK SO THEY TOOK HER TO THE HOSPITAL. ROOMMATE REPORTED THE DOCTOR GAVE THE PT AN IV DRIP AND SHE WAS IN THE HOSPITAL FOR ABOUT A WEEK. ROOMMATE STATED THE PT HAD KETOACIDOSIS; DOES NOT KNOW IF THE DOCTOR DIAGNOSED IT OR NOT. NO BLOOD GLUCOSE READINGS WERE PROVIDED. PT'S NORMAL BLOOD GLUCOSE RANGE IS 105 - 125 MG/DL. ROOMMATE DOES NOT KNOW IF THE PT WAS IN A TEMPORARY BASAL RATE. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O| R INSULIN INFUSION SET (DOT: (B)(6) 2010)| INSULIN (DATE OF TREATMENT (B)(6) 2010)