BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811147 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01613
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    May 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HER BLOOD GLUCOSE HAS BEEN RUNNING HIGH AND HER THERAPIST PUT HER ON HER BACKUP INFUSION DEVICE. PT STATED SHE HAS BEEN ON THE BACKUP INFUSION DEVICE FOR 2 WEEKS. PT REPORTED HER THERAPIST IS A DOCTOR AT HER ENDOCRINOLOGIST'S OFFICE. PT STATED THE ELEVATED READINGS STARTED ABOUT A MONTH AGO AND LASTED FOR 2 WEEKS. PT REPORTED HER FEELINGS WERE ANYWHERE FROM 300-500 MG/DL PLUS. PT'S NORMAL BLOOD GLUCOSE RANGE IS 120-160 MG/DL. PT STATED ONE DAY HER BLOOD GLUCOSE WAS OVER 600 MG/DL, SHE VOMITED AND THEN GOT DEHYDRATED; DOES NOT RECALL WHAT DAY THAT WAS. PT REPORTED SHE DID NOT GO TO THE HOSPITAL FOR ANY OF THE ELEVATED READINGS. PT STATED HER READINGS HAVE BEEN BACK TO NORMAL AS SOON AS SHE WENT ON THE BACKUP INFUSION DEVICE. PT REPORTED SHE DID NOT RECEIVE ANY ERRORS OR ALERTS. PT STATED HER INFUSION TUBING IS CHANGED EVERY 4 DAYS AND SHE CHANGED IT MORE OFTEN DURING THE TIME OF HER ELEVATED BLOOD GLUCOSE. PT REPORTED SHE CHANGES THE CANNULA WITH EVERY TUBING CHANGE. ADVISED THE RECOMMENDATION FOR CHANGING THE INFUSION SITE IS EVERY 72 HOURS. REMINDED PT TO CHANGE HER CANNULA EVERY 3 DAYS AND TO USE A STANDARD ALKALINE BATTERY IN THE INFUSION DEVICE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT 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 50 YR INSULIN INFUSION SET| INSULIN