BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1082215 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01032
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 25, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 300-400 MG/DL AND DIZZINESS FOR THE PAST WEEK. HE WAS ABLE TO LOWER HIS BLOOD GLUCOSE BY INJECTING INSULIN VIA SYRINGE. HE STATED THAT WHEN USING INSULIN INJECTIONS HE SOMETIMES MAY "OVERDOSE" RESULTING IN LOW BLOOD GLUCOSE. HE STATED THAT 3 DAYS AGO, WHILE RIDING THE LAWN MOWER, HE "BLACKED OUT" AND WAS FOUND BY HIS NEIGHBOR. HE WAS GIVEN ORANGE JUICE AND HIS BLOOD GLUCOSE ELEVATED TO 72 MG/DL 20 MINUTES LATER. UPON FOLLOW UP ON THE FOLLOWING MONTH, THE PATIENT STATED THAT HE CONTINUES TO EXPERIENCE ELEVATED BLOOD GLUCOSE READINGS WITH HIS INFUSION DEVICE, AND HE HAS AN APPOINTMENT WITH HIS PHYSICIAN. HE STATED THAT HE SWITCHED TO PREVIOUS INFUSION DEVICE AND HIS BLOOD GLUCOSE RETURNED TO NORMAL. 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 INFUSION SET| INSULIN