BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1883354 · Received June 18, 2010

    Report

    Report Number
    2183996-2010-01295
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    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 EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THAT ON (B)(6) 2010, THE CARTRIDGE VOLUME IN HER INSULIN CARTRIDGE DIFFERED FROM THE VOLUME REMAINING ON THE INFUSION DEVICE. PT STATED SHE RECEIVED THE LOW ALERT (A1) AND CONTINUED TO USE THE INFUSION DEVICE. PT REPORTED SHE LOOKED AT THE INSULIN CARTRIDGE LATER THAT DAY AND FOUND IT WAS COMPLETELY EMPTY AND THE INFUSION DEVICE STILL DISPLAYED UNITS REMAINING. REVIEWED THE CARTRIDGE CHANGE PROCESS AND MANUALLY ADJUSTING THE PISTON ROD TO FIT THE AMOUNT OF INSULIN INSIDE OF THE INSULIN CARTRIDGE. PT REPORTED HER BLOOD GLUCOSE READING WAS 64 MG/DL BEFORE LUNCH ON (B)(6) 2010; DID NOT BOLUS FOR THE CARBOHYDRATES THAT SHE HAD FOR LUNCH. PT STATED 2 HOURS LATER HER BLOOD GLUCOSE READING WAS 191 MG/DL. PT REPORTED SHE DID NOT PERFORM A CORRECTION BOLUS AT THAT TIME, BUT STATED SHE WOULD BOLUS WHEN SHE ARRIVED HOME. PT STATED SHE WAS WITH HER TRAINER DURING THAT TIME. PT REPORTED SHE CHANGED THE INSULIN CARTRIDGE AND ATE DINNER WHEN SHE ARRIVED HOME AND THEN PERFORMED A BOLUS FOR THE CARBOHYDRATES BUT DID NOT BOLUS FOR CORRECTION. PT STATED HER BLOOD GLUCOSE WHEN SHE WOKE UP THIS MORNING WAS 74 MD/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 70-140 MG/DL. PT REPORTED HER INFUSION DEVICE DID NOT DISPLAY ANY ERRORS OR OCCLUSIONS. PT STATED HER INFUSION SITE HAD BEEN IN USE FOR 3 OR 4 DAYS DURING THE INCIDENT. ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS. PT REPORTED SHE HAS SCAR TISSUE BUT AVOIDS THOSE SITE LOCATIONS. PT STATED HER MEDICAL PROFESSIONAL ADJUSTED HER BASAL RATE PROFILE ON (B)(6) 2010 AND HER STRESS LEVEL IS SLIGHTLY ELEVATED. ON F/U CALL ON (B)(6) 2010, PT REPORTED EVERYTHING IS WORKING FINE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    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 55 YR Required Intervention INSULIN INFUSION SET| INSULIN