BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3070665 · Received April 22, 2013

    Report

    Report Number
    2183996-2013-00722
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 17, 2013
    Report Date
    August 20, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    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 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 COMPLIES WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE BEGAN TO EXPERIENCE HYPERGLYCEMIA OF UP TO 580 MG/DL ON (B)(6) 2013. SHE CHANGED THE ACCESSORIES AND DELIVERED INSULIN VIA THE INFUSION DEVICE BUT WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE WENT TO THE HOSPITAL AROUND 12:00 P.M. ON (B)(6) 2013, AND HER BLOOD GLUCOSE WAS 405 MG/DL AND SHE WAS VOMITING. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS, AND THE INFUSION DEVICE WAS REMOVED. SHE RECEIVED AN INSULIN INFUSION AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. A DIABETES COUNSELOR DETECTED INSULIN IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE, AND THE PATIENT BELIEVES THE INSULIN DELIVERY IS TOO LOW. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172075 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR Hospitalization| R