BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 5100805 · Received September 24, 2015

    Report

    Report Number
    3011393376-2015-03620
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 31, 2015
    Report Date
    November 16, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE INFUSION DEVICE. THE PATIENT DIDN'T FEEL WELL FOR "SEVERAL" DAYS WITH SYMPTOMS OF WEAKNESS AND FATIGUE. THE BLOOD GLUCOSE LEVELS WERE BETWEEN "220-280 MG/DL." THE PATIENT DID A BLOOD TEST AT THE CLINIC AND WAS INSTRUCTED TO GO TO THE HOSPITAL BY HER FAMILY DOCTOR. THE BLOOD SUGAR RESULT AT THE CLINIC WAS UNKNOWN. AT THE HOSPITAL, THE PATIENT WAS TREATED WITH INSULIN. THE HOSPITAL RESULTS WERE UNKNOWN. THE PATIENT WAS IN THE HOSPITAL FOR "LESS THAN A DAY." THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631349 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR Hospitalization| R