BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1082231 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01098
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THE UP/DOWN BUTTONS ON HER INSULIN INFUSION DEVICE ARE NOT RESPONDING TO PRESSES. SHE STATED, SHE DOES NOT KNOW HOW LONG THIS HAS BEEN GOING ON AND THINKS SHE MAY NOT HAVE GOTTEN HER BOLUSES AS SHE HAS HAD ELEVATED BLOOD GLUCOSE READING OF 342-370 MG/DL. SHE SAID, HER NORMAL RANGE IS AROUND 150 MG/DL. SYMPTOMS ARE THIRST AND FATIGUE. SHE STATED SHE HAS BEEN BOLUSING BUT HAS NOT BEEN LISTENING FOR THE CONFIRMATION BEEPS UNTIL YESTERDAY. THE PT STATED, SHE IS CURRENTLY USING THE STANDARD BOLUS FEATURE TO GIVE HERSELF BOLUSES. SHE SAID, SHE WILL SWITCH TO HER BACKUP INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND 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