BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4131833 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07488
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 1, 2014
    Report Date
    March 9, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS RECENTLY AND ALLEGES IT IS DUE TO THE PUMP NOT DELIVERING INSULIN PROPERLY. PATIENT STATED HIS BLOOD GLUCOSE LEVELS HAVE BEEN IN THE 20'S MMOL/L; ABLE TO SELF-TREAT BY GOING OFF OF THE PUMP AND USING HIS BACKUP THERAPY OF SYRINGES. NO ADVERSE EVENT REPORTED. PUMP REPLACED AND EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613039 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1