BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 5759673 · Received June 29, 2016

    Report

    Report Number
    3011393376-2016-04255
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    May 29, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 ALLEGED THAT THE INFUSION DEVICE WAS DELIVERING AN INACCURATE AMOUNT OF INSULIN. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS, AND HAD SYMPTOMS OF VOMITING. DURING THE EVENT THE PATIENT'S BLOOD GLUCOSE READING WAS 350 MG/DL, AND THE PATIENT WAS DIAGNOSED WITH "DIABETIC ACIDOSIS." AT THE HOSPITAL THE PATIENT WAS TREATED WITH HUMALOG , NOVORAPID, AUGUMENTIN 0.9 % NACL, PWE, METOCLO KLINT, HELICID, ESTAZONAL, AND TORECAN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2016. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411626 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R