BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4180386 · Received October 17, 2014

    Report

    Report Number
    1823260-2014-08006
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 28, 2014
    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

    CALLER REPORTED THE PUMP DOES NOT DELIVER INSULIN ANYMORE. ON (B)(6) 2014 AT 5:30 PM, SHE MEASURED 185 MG/DL AFTER CHANGING THE INFUSION SET. CUSTOMER PRIMED THE TUBE, EVERYTHING SEEMED TO BE OK. AT 9 PM (SAME DAY), SHE MEASURED 503 MG/DL, THERE WAS NO INSULIN IN THE TUBE. CUSTOMER TRIED TO DELIVER A BOLUS BUT NO INSULIN CAME OUT OF THE TUBE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663065 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 008 YR UNSPECIFIED INSULIN