BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2921674 · Received January 11, 2013

    Report

    Report Number
    2183996-2012-02141
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 30, 2012
    Manufacturer
    ROCHE HEALTH SOLUTAIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT THE INFUSION DEVICE DISPLAYED AN E4 (OCCLUSION) ERROR WHILE ATTEMPTING TO BOLUS AND HE WAS ASSISTED IN CLEANING THE ERROR AND COMPLETING THE BOLUS. THE PATIENT'S WIFE THEN REPORTED THAT THE PATIENT WAS CURRENTLY IN THE HOSPITAL AND HIS BLOOD GLUCOSE WAS ELEVATED TO 500 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-180 MG/DL. THE PATIENT STATED HE HAD BEEN HOSPITALIZED DUE TO ANOTHER ISSUE AND HIS BLOOD GLUCOSE WAS ELEVATED BECAUSE THE HOSPITAL STAFF WOULD NOT ALLOW HIM TO PERFORM HIS OWN BOLUSES OR MONITOR HIS OWN BLOOD GLUCOSE LEVELS. HE WAS ONLY PERMITTED TO REMAIN CONNECTED TO THE INFUSION DEVICE FOR BASAL RATE DELIVERY AND RECEIVED BOLUSES BY INSULIN INJECTIONS. HIS BLOOD GLUCOSE HAD BEEN ELEVATED FOR 2-3 DAYS AND HE STATED HE WAS GOING TO BEGIN BOLUSING THROUGH THE INFUSION DEVICE TO LOWER HIS READINGS. UPON FOLLOW UP ON (B)(6) 2013 THE PATIENT'S WIFE STATED THAT THE PATIENT WAS ABLE TO SELF-TREAT TO LOWER HIS BLOOD GLUCOSE AND HE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT WAS NOT ALWAYS CAPABLE TO SELF-TREAT ELEVATED BLOOD GLUCOSE WHILE HOSPITALIZED. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17791 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTAIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R RELATED ACCESSORIES| INSULIN INFUSION PUMP| DATE OF THERAPY: UNK| INSULIN