BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2985432 · Received March 1, 2013

    Report

    Report Number
    2183996-2013-00283
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 10, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): NO PRODUCT HAS BEEN REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT ON (B)(6) 2013 AT 4:30PM THE PATIENT WAS HOSPITALIZED WITH KETOACIDOSIS AND AN ELEVATED BLOOD GLUCOSE LEVEL OF 22 MMOL/L (396 MG/DL). THE PATIENT WAS DISCONNECTED FROM THE INFUSION DEVICE WHILE IN THE HOSPITAL AND TREATED WITH INSULIN INJECTIONS. DURING THAT NIGHT HER BLOOD GLUCOSE LEVELS RANGED FROM 14- 19 MMOL/L (252-342 MG/DL). THE PATIENT HAS HAD A VIRAL INFECTION AND INCREASED STRESS AT WORK. THE DOCTOR AND THE PATIENT MADE NO ALLEGATION AGAINST THE PERFORMANCE OF THE INFUSION DEVICE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88846 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R