BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1548761 · Received November 25, 2009

    Report

    Report Number
    2183996-2009-02758
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 28, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    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 OF 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

    THE PATIENT REPORTED THAT THE INFUSION MAKES LOUD NOISES DURING PISTON ROD RETRACTION, AND SHE DOES NOT BELIEVE THE DEVICE DELIVERS INSULIN CORRECTLY. SHE REPORTED EXPERIENCING ERRATIC BLOOD GLUCOSE OF 150-404 MG/DL DESPITE BOLUSING AND CHANGING ACCESSORIES. IN 2009, THE PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE AND HAD NO FURTHER ISSUES. HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INSULIN| INSULIN INFUSION SET