BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2982053 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00164
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ROCHE HEALTH CARE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE PUMP CASE IS DAMAGED DUE TO A HARD MECHANICAL IMPACT DURING USE. THE CHECK BUTTON WAS DAMAGED BY A POINTY OBJECT WHICH RESULTED IN A FAULTY SNAP DOME. THE CHECK BUTTON IS ALWAYS ACTIVE, AND DUE TO THIS PROBLEM, THE OTHER BUTTONS ARE NON-FUNCTIONAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE CHECK BUTTON ON THE PT'S INFUSION DEVICE WAS NOT FUNCTIONING, THE DEVICE DISPLAYED A3 (SET TIME/DATE), BUT THE PT COULD NOT CONFIRM THE ALERT DUE TO THE CHECK BUTTON NOT FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55312 ACCU-CHEK D-TRONPLUS LZG ROCHE HEALTH CARE SOLUTIONS INC. 00700006842 NA

    Patients

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