BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1000994 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00170
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED HE RECEIVES AN E8 (POWER INTERRUPT) MESSAGE ON HIS INSULIN INFUSION DEVICE EVERY DAY. HE STATED HE HAS CHANGED HIS BATTERY FREQUENTLY. HE SAID HE HAS ALSO EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS OF 250 MG/DL WITH HIS NORMAL RANGE BEING BELOW 130 MG/DL. DURING TROUBLESHOOTING, THE PT STATED HE HAS NOTICED INSULIN COMING OUT OF HIS SITE, SO SCAR TISSUE MAY BE A CONCERN. HE SAID HE DOES NOT BOLUS ONE UNIT OF INSULIN AFTER INSERTING A NEW HEADSET. THE PT WAS ADVISED TO ALWAYS DO SO. THE PT STATED HE IS WORKING OUTSIDE IN THE COLD. HE WAS ADVISED THAT THE MFR DOES NOT RECOMMEND DIRECT EXPOSURE TO TEMP RANGES OVER 104 F AND BELOW 41 F, SO HE NEEDS TO WEAR THE DEVICE SO HE CAN KEEP THE DEVICE WITHIN THAT RANGE. ON FOLLOW UP THE NEXT DAY, THE PT STATED HE DID NOT RECEIVE AN E8 ALL DAY BUT THAT HIS BLOOD GLUCOSE READINGS ARE STILL SLIGHTLY ELEVATED. HE SAID HIS BASAL RATES HAVE BEEN ADJUSTED RECENTLY. HE SAID HE CONTINUES TO USE THE SIDES OF HIS STOMACH ALTHOUGH HE HAS SCAR TISSUE THERE. THE PT WAS ADVISED TO USE OTHER AREAS FOR HIS SITE. ON FURTHER FOLLOW UP, THE PT STATED THAT "THINGS ARE MUCH BETTER." HE STATED HE IS USING NEW AREAS ON HIS STOMACH AND THIS HAS IMPROVED HIS BLOOD GLUCOSE READINGS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS 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 YR Required Intervention INSULIN INFUSION SET| INSULIN