BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1202739 · Received October 14, 2008

    Report

    Report Number
    2183996-2008-01589
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 6, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT ON THREE DAYS EARLIER, HER BLOOD GLUCOSE WAS ELEVATED TO 477 MG/DL AND SHE DID NOT FEEL WELL. SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION TUBING AND BOLUSED 6 UNITS OF INSULIN. HER BLOOD GLUCOSE LOWERED TO 364 MG/DL AND SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION TUBING AGAIN AND BOLUSED 4-5 UNITS OF INSULIN. ON THE NEXT DAY, SHE INCREASED HER BASAL RATE BY 0.5 UNITS PER HOUR. ON THE DAY PRIOR TO ORIGINAL DATE AT 7:00 AM HER BLOOD GLUCOSE MEASURED 290 MG/DL AND SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND BOLUSED 3 UNITS OF INSULIN. AT 9:30 AM HER BLOOD GLUCOSE MEASURED 280 MG/DL. SHE STATED THAT WHEN SHE CHANGED THE INSULIN CARTRIDGE FOR THE 2ND TIME THE INFUSION DEVICE READ THAT THE PISTON ROD WAS RETRACTED TO THE 315 MARK BUT WHEN THE INSULIN CARTRIDGE WAS INSERTED INSULIN LEAKED OUT. SHE STATED THAT ONLY 285 UNITS OF INSULIN WAS IN THE INSULIN CARTRIDGE. SHE STATED THAT SHE DID NOT EXTEND THE PISTON ROD TO THE 285 MARK. SHE STATED THAT SHE DOES NOT BELIEVE SHE WAS RECEIVING ENOUGH INSULIN. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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