BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1012664 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00301
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 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 THAT THE KEY LOCK FEATURE OF HIS INFUSION DEVICE WAS ON AND HE WAS NOT ABLE TO TURN IT OFF. HE STATED THAT HE DID NOT KNOW HOW THE KEY LOCK FEATURE GOT TURNED ON OR WHEN IT WAS TURNED ON. PRIOR TO CALLING HE REMOVED AND REINSERTED THE BATTERY. HE WAS ADVISED TO PRESS AND HOLD THE MENU AND DOWN BUTTONS FOR 3 SECONDS. HE STATED HE DID THIS AND WAS UNABLE TO UNLOCK THE KEYS. HE WAS INSTRUCTED TO REMOVE AND REINSERT THE BATTERY AND PRESS THE MENU BUTTON UNTIL HE SAW THE "STANDARD SETUP" SCREEN. HE WAS THEN ADVISED TO PRESS THE CHECK BUTTON AND UP BUTTON TO UNLOCK THE KEYS. HE STATED THAT DUE TO THE LOCKED BUTTONS HE WAS UNABLE TO BOLUS AND HIS BLOOD GLUCOSE ELEVATED TO 300 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. HE BOLUSED IMMEDIATELY UPON UNLOCKING THE KEYS. UPON FOLLOW UP ON THE NEXT DAY, THE PATIENT STATED HE WAS DOING FINE AND HIS INFUSION DEVICE WAS FUNCTIONING PROPERLY. 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