BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1083305 · Received July 28, 2008

    Report

    Report Number
    2183996-2008-01069
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 5, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 350 MG/DL WITH HIS TYPICAL READING BEING 180 MG/DL. HE CORRECTED HIS READING BY GIVING HIMSELF AN INSULIN INJECTION. HE STATED, HE REC'D AN E7 (ELECTRONIC ERROR) ON HIS INSULIN INFUSION DEVICE WHILE THE PISTON ROD WAS RETURNING. HE STATED HE FEELS "THE PUMP WAS NOT DOING WHAT IT WAS SUPPOSE TO." THE PT WAS IN A HURRY AND DID NOT HAVE TIME FOR TROUBLESHOOTING. ON FOLLOW UP WITH THE PT ON FOUR DAYS LATER, THE PT STATED HIS BLOOD GLUCOSE READINGS ARE BACK TO HIS NORMAL RANGE AND HE HAS HAD NO FURTHER ISSUES. THE PT WAS IN A HURRY AND DECLINED FURTHER DISCUSSION. 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 Required Intervention INSULIN| INSULIN INFUSION SET