BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2161227 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02316
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    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
    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

    PT STARTED INFUSION DEVICE ON (B)(6) 2010. FROM (B)(6) 2010, PT EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE AS HIGH AS 465 MG/DL. PT CORRECTED HYPERGLYCEMIA WITH INSULIN INJECTIONS. ON (B)(6) 2010, PT STARTED THE BACKUP INFUSION DEVICE AND EXPERIENCED NO FURTHER CONCERNS. PT BELIEVES THE INSULIN DELIVERY OF PRIMARY INFUSION DEVICE WAS TOO LOW. INFUSION HEADSET IS CHANGED EVERY 2 - 3 DAYS AND INFUSION TUBING AND INSULIN CARTRIDGE EVERY 7 DAYS. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. PT DID NOT LOOSE CONSCIOUSNESS. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention INSULIN| INSULIN INFUSION SET