BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4212912 · Received October 30, 2014

    Report

    Report Number
    1823260-2014-08386
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 6, 2014
    Report Date
    January 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGES THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN. THE PATIENT STATED THAT THE INFUSION DEVICE HAD SHUT OFF DURING THE NIGHT AND HIS BLOOD GLUCOSE LEVELS WENT LOW. HE WAS ABLE TO SELF-TREAT BY EATING DEXTROSE. HE STATED THAT AFTER CHANGING THE BATTERY IN THE DEVICE, THE DATE AND TIME SETTINGS WERE NOT RETAINED. THE PATIENT'S BASAL RATE IS 120 UNITS OF INSULIN PER DAY. HE STATED THAT DURING A DAY THAT HE HAD PROGRAMMED A TEMPORARY BASAL RATE OF 40%, HE RECEIVED A TOTAL BASAL RATE OF 315 UNITS OF INSULIN THAT DAY. 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
    695897 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR UNSPECIFIED INSULIN