BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1241800 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01734
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    August 16, 2008
    Report Date
    November 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S VENDOR REPORTED THAT THE PATIENT EXPERIENCED E6 (MECHANICAL) ERRORS AND SHE BELIEVES THIS LED TO HYPOGLYCEMIA AND HYPERGLYCEMIA. ON THE PREVIOUS MONTH, THE PATIENT'S BLOOD GLUCOSE MEASURED 1.8 MMOL/L (32 MG/DL) AND SHE BECAME UNCONSCIOUS AND WAS HOSPITALIZED FOR A WEEK. SHE STATED THAT ON THE FIRST DAY, AN E6 (MECHANICAL) ERROR WAS DISPLAYED ON THE INFUSION DEVICE. THE ERROR WAS CLEARED BY CHANGING THE BATTERY, INFUSION SET, AND INSULIN CARTRIDGE. THE PATIENT BOLUSED 5 UNITS OF INSULIN FOR BREAKFAST AND AT 12:00PM, SHE EXPERIENCED HYPOGLYCEMIA AND FELL, FRACTURING HER 4TH AND 5TH VERTEBRA. ON A WEEK PRIOR TO ORIGINAL DATE, THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OF 13.7-24.8 MMOL/L (246-446 MG/DL). SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE LOWERED TO 3.5 MMOL/L (63 MG/DL). NO FURTHER INFO IS AVAILABLE. PRODUCT WAS 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