BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3012059 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00435
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 2, 2013
    Report Date
    July 30, 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
    UK
    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. PRODUCTION REPORTS WERE REVIEWED. (B)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE UNRESPONSIVE BY HIS PARENTS IN THE MORNING. THE PATIENT WAS TAKEN TO THE HOSPITAL. ON (B)(6) 2013, THE PATIENT TOLD HIS PARENTS THAT HE WAS NOT FEELING WELL AND THOUGHT HE MIGHT HAVE A BUG AND WAS VOMITING. THE PATIENT AND HIS MOTHER NOW THINK THE INFUSION DEVICE WAS DELIVERING TOO LOW AND AMOUNT OF INSULIN. THE PATIENT DISCONNECTED FROM THE INFUSION DEVICE WHEN HE WAS ADMITTED TO THE HOSPITAL, BUT IT WAS LEFT IN RUN MODE. THE FOLLOWING DAY THE PATIENT'S MOTHER STATED THAT NO INSULIN HAD COME THROUGH THE TUBING AND THE DEVICE HAD NOT DISPLAYED ANY ALARMS. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115395 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 021 YR Hospitalization| R