BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3840380 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03867
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 10, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED AS HIGH AS 29.9 MMOL/L AND HE THINKS HIS INFUSION DEVICE IS NOT DELIVERING INSULIN. HE DISCONNECTED THE INFUSION SET FROM HIS BODY AND PROGRAMMED A BOLUS OF 5 UNITS OF INSULIN AND NOT INSULIN WAS SEEN COMING OUT OF THE END OF THE TUBING. 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
    317845 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR