BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2833401 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01658
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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) 2012, IT WAS REPORTED THAT THE PATIENT'S INFUSION DEVICE DID NOT DISPLAY A1 (CARTRIDGE LOW). THE PATIENT IS BLIND; THEREFORE, HE CANNOT SEE THE LEVEL OF INSULIN IN THE CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP