BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1953437 · Received December 30, 2010

    Report

    Report Number
    2183996-2010-02704
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED, HE WAS HOSPITALIZED ON (B)(6) 2010. HE STATED A4 (CARTRIDGE/ADAPTER) ALERT HAD BEEN DISPLAYED ON THE INFUSION DEVICE. WHEN A4 WAS INITIALLY DISPLAYED, HE WAS "ON THE ROAD" AND HAD TO RETURN HOME BECAUSE HE DID NOT HAVE SUPPLIES WITH HIM. THE A4 RECURRED WHILE HE WAS HOME AND HE WAS NOT ABLE TO CLEAR IT. HE BECAME UNCONSCIOUS DUE TO HYPOGLYCEMIA (BLOOD GLUCOSE VALUE NOT PROVIDED). HE WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. NO FURTHER INFO IS AVAILABLE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS INSULIN INFUSION DEVICE FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN INFUSION SET| INSULIN