BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 3251528 · Received July 29, 2013

    Report

    Report Number
    2183996-2013-01413
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 26, 2013
    Report Date
    September 18, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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 A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE CHECK-KEY DOES NOT CONSTANTLY RESPOND. THE SNAP DOME TENSION IS IMPAIRED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. PATIENT STATED THE BUTTON CANNOT BE PRESSED. 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. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352571 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR