BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2932134 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00055
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE HEALTH 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

    BITE MARKS AT THE PUMP HOUSING AND THE DOWN-BUTTON. THE DOWN-BUTTON IS DAMAGED AND DEFECT THROUGH MISUSE. THE DOWN-BUTTON WAS DAMAGED BY A POINTY OBJECT WHICH RESULTED IN A FAULTY SNAP DOME. THE DOWN BUTTON IS ALWAYS ACTIVE. DUE TO THIS PROBLEM THE OTHER BUTTONS CAN'T BE OPERATED AND DO NOT RESPOND.

    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

    PATIENT REPORTED THE CONFIRM BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. PATIENT STATED SHE NOTICED THE BUTTON IS NOT WORKING AND SWITCHED TO THE BACKUP INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28395 ACCU-CHEK D-TRONPLUS LZG ROCHE HEALTH SOLUTIONS INC. 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES