BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2800069 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01595
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    May 1, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ROCHE INSULIN INFUSION 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

    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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THE INFUSION DEVICE DOES NOT CORRECTLY PROVIDE E4 OCCLUSION ERRORS. SHE HAS EXPERIENCED BLOOD GLUCOSE LEVELS OF 27 TO >450 MG/DL, AND SHE BELIEVES THE INSULIN DELIVERY IS INACCURATE. THIS HAS OCCURRED SINCE (B)(6) 2012, AND SHE HAS NOT HAD AN INFECTION OR STARTED NEW MEDICATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 LZG ROCHE INSULIN INFUSION SYSTEMS INC. 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES