BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4792568 · Received May 22, 2015

    Report

    Report Number
    3011393376-2015-00611
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 WAS SWEATING AND UNAPPROACHABLE. THE PATIENT WAS OFFERED SUGARY DRINKS, BUT DECLINED. AN AMBULANCE WAS CALLED AND THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. AT THAT TIME SHE ACCEPTED THE SUGARY DRINKS. A BOLUS OF 3 UNITS OF INSULIN WAS FOUND IN THE INFUSION DEVICE THAT THE PATIENT STATES SHE DID NOT PROGRAM. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333725 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR Required Intervention