BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 3013362 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00460
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    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

    CONCLUSION: THE COMPLAINT CAN BE VERIFIED, AS A RESULT, SOME SEGMENTS OF THE DISPLAY ARE NOT INDICATED. MECHANICAL STRESS AND AN INSUFFICIENT GLUING PROCESS BY THE MANUFACTURER CAUSED THE SEPARATION OF THE DISPLAY GLASS. THE PUMP WILL BE STORED IN IU.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED THE DISPLAY OF THE INFUSION DEVICE HAS SOME PIXELS MISSING. PATIENT STATED YOU CAN MAKE A MISINTERPRETATION FROM THE BOLUS OR BASAL AMOUNT. 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
    116140 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR