BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IACCU-CHEK SPIRIT

    MDR report key: 1252784 · Received December 4, 2008

    Report

    Report Number
    2183996-2008-01818
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 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
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED AN ELEVATED BLOOD GLUCOSE READING AT BEDTIME LAST NIGHT OF 218 MG/DL WITH HIS TARGET READING BEING 140 MG/DL. HE BOLUSED 6 UNITS OF INSULIN THROUGH HIS INFUSION DEVICE AND THIS MORNING HIS READING WAS 210 MG/DL. THROUGHOUT THE DAY HIS READINGS HAVE BEEN 289 MG/DL, 325 MG/DL AND 348 MG/DL. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO CHECK THE TIME AND BASAL RATES ON HIS INFUSION DEVICE AND HE CONFIRMED THEY ARE ACCURATE. HE CHANGED HIS INSULIN CARTRIDGE AND INFUSION SET YESTERDAY AND AGAIN TODAY AT 3PM. HE SAID HE GENERALLY CHANGES ACCESSORIES EVERY 2.5 DAYS. HE INSERTS HIS HEADSET INTO HIS STOMACH. SITE ROTATION WAS DISCUSSED WITH THE PATIENT. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. THE PATIENT CHECKED HIS BLOOD GLUCOSE AT THE END OF THE CALL AND IT HAD LOWERED TO 249 MG/DL. HE WAS ADVISED TO MONITOR HIS READINGS. ON FOLLOW UP WITH THE PATIENT THE NEXT DAY, HE STATED HIS BLOOD GLUCOSE LOWERED TO 90 MG/DL BY 9PM LAST NIGHT AND HIS READING THIS NORMING WAS 113 MG/DL AND HE HAS STAYED WITHIN HIS TARGET RANGE ALL DAY. HE SAID HIS SITE WAS NOT PAINFUL OR IRRITATED WHEN HE REMOVED THE HEADSET AND THE ONLY ABNORMAL THING WAS HIS BLOOD GLUCOSE WOULD NOT DECREASE WITH BOLUSES THROUGH HIS INFUSION DEVICE OR THROUGH MANUAL INJECTIONS. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention INSULIN INFUSION SET| INSULIN