BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1071410 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00994
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    March 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 6/29/2008, THE PT REPORTED THE DOWN BUTTON ON HER INSULIN INFUSION DEVICE IS NOT PROPERLY WORKING. SHE STATED SHE BELIEVES THIS HAS CONTRIBUTED TO HER ELEVATED BLOOD GLUCOSE READINGS OVER THE PAST FEW MONTHS. SHE STATED SHE HAS HAD READINGS IN THE 300'S MG/DL EVERY THIRD DAY WITH HER TARGET READING BEING 100 MG/DL. SHE STATED SHE HAS HAD NO SYMPTOMS AND TREATS HER READINGS BY USING THE "QUICK BOLUS" FEATURE. SHE SAID SHE DOES NOT WAIT TO HEAR/FEEL THE CONFIRMATION BEEPS AND DOES NOT KNOW IF THE BOLUSES WERE DELIVERED. TO TROUBLESHOOT, THE PT CONFIRMED THE TIME AND BASAL RATES ON HER INFUSION DEVICE ARE ACCURATE AND SHE HAS NOT REC'D ANY OCCLUSION OR OTHER ALARMS. SHE STATED SHE CHANGES HER INFUSION HEADSET EVERY 2-3 DAYS AND HER CARTRIDGE AND TUBING EVERY 8 DAYS. THE PT WAS ADVISED TO CHANGE HER CARTRIDGE AND TUBING EVERY 6 DAYS. SHE SAID SHE HAS GAINED A FEW POUNDS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET