BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3901867 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04747
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 20, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING AN ISSUE OF THE BATTERIES IN THE PATIENT'S INFUSION DEVICE BEING DEPLETED TOO QUICKLY, IT WAS REPORTED THAT THE PATIENT ALLEGES HER PRIMARY INFUSION DEVICE DELIVERS TOO LOW AN AMOUNT OF INSULIN. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OF 300-HI ON HER PRIMARY DEVICE. ON HER BACKUP DEVICE HER BLOOD GLUCOSE LEVELS WERE 75-181. THE PATIENT'S 24 HOUR BASAL RATE ON HER PRIMARY DEVICE IS 24 UNITS OF INSULIN. THE PATIENT'S 24 HOUR BASAL RATE ON HER BACKUP DEVICE IS 48 UNITS OF INSULIN. THE PATIENT STATED THAT SHE BOLUSED THE DIFFERENCE AND THAT THE DIFFERENCE IN THE BASAL RATES WAS NOT THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380415 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1