BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1083299 · Received July 28, 2008

    Report

    Report Number
    2183996-2008-01077
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 07/11/2008, THE PATIENT REPORTED THAT 2 DAYS AGO, SHE EXPERIENCED ELEVATED BLOOD GLUCOSE AFTER BEING DISCONNECTED FROM HER INFUSION DEVICE WHILE SWIMMING. SHE BOLUSED TO LOWER HER BLOOD GLUCOSE BUT HER LEVELS REMAINED ELEVATED. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A HEADACHE AND ELEVATED BLOOD GLUCOSE OF 200-300 MG/DL. TODAY, HER BLOOD GLUCOSE WAS NORMAL (80-150 MG/DL) BUT SHE NOTICED INSULIN IN THE CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE AND SHE RECEIVED THE SYSTEM ALARM (E7) TWICE. SHE IS CONCERNED THAT THE ELEVATED BLOOD GLUCOSE AND ALARMS ARE DUE TO INSULIN IN THE CARTRIDGE COMPARTMENT. THIS IS THE PATIENT'S BACKUP INFUSION DEVICE AND SHE STATED THAT SHE WILL SWITCH TO HER PRIMARY DEVICE. 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