BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1420604 · Received July 21, 2009

    Report

    Report Number
    2183996-2009-01502
    Event Type
    Injury
    Date Received
    July 21, 2009
    Date of Event
    April 22, 2009
    Report Date
    June 22, 2009
    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
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2009, THE PATIENT REPORTED THE DOWN BUTTON ON HER INSULIN INFUSION DEVICE DOES NOT WORK AND THE UP BUTTON WORKS INTERMITTENTLY. SHE SAID THE ISSUE BEGAN A COUPLE OF MONTHS AGO WHICH SHE NOTICED BECAUSE HER DEVICE DID NOT BEEP WHEN THE BUTTON WAS PRESSED. SHE STATED SHE ALSO HAD AN ELEVATED BLOOD GLUCOSE READING OF 426 MG/DL WITH HER TARGET READING BEING 140-200 MG/DL. SYMPTOMS WERE NAUSEA, GROGGINESS AND NOT FEELING WELL. SHE CORRECTED HER READING BY BOLUSING INSULIN VIA HER DEVICE. SHE STATED BOTH BUTTONS POP UP WHEN PRESSED. HER DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN. THE PATIENT DID NOT REQUIRE 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 55 YR Required Intervention INSULIN| INSULIN INFUSION SET