BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3200922 · Received July 2, 2013

    Report

    Report Number
    2183996-2013-01202
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    August 21, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT DOES NOT CONTRIBUTE TO THE PROBLEM MENTIONED BY THE PATIENT AND IS NOT REQUIRED FOR FURTHER INVESTIGATION. THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION. PRODUCTION REPORTS WERE REVIEWED. NO PRODUCT WAS 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. NO PRODUCT REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PATIENT PERFORMED AN INSULIN CARTRIDGE CHANGE IN HIS INFUSION DEVICE, BUT HE FORGOT TO PUT A NEW CARTRIDGE IN THE DEVICE. THE USER IS INSTRUCTED TO PRIME THE DEVICE AFTER A CARTRIDGE CHANGE UNTIL INSULIN CAN BE SEEN COMING OUT OF THE END OF THE INFUSION TUBING. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 584 MG/DL AND PH OF 7.18. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT OF THE HOSPITAL ON (B)(6) 2013. THE INFUSION DEVICE WAS NOT REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303396 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR Hospitalization