BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3012024 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00440
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    June 25, 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
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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. PRODUCTION REPORTS WERE REVIEWED. NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS SINCE (B)(6) 2013. THE PATIENT EXPERIENCED SICKNESS AND POSITIVE KETONE BODIES. THE PATIENT WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE LEVEL OF 380 MG/DL. SHE WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS. THE PATIENT RECEIVED INSULIN SERUM THERAPY AT THE HOSPITAL. SHE ALLEGED THAT THE INFUSION DEVICE WAS RELATED TO HER HYPERGLYCEMIA, HOWEVER, TROUBLESHOOTING WITH THE PATIENT DID NOT IDENTIFY ANY PROBLEMS WITH THE DEVICE. THE PATIENT CONTINUES TO USE THE SAME DEVICE AND HER BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116054 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR Hospitalization| R