BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 3092875 · Received May 3, 2013

    Report

    Report Number
    2183996-2013-00786
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 11, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. HISTORY LIST: ALL PROGRAMMED BOLUSES WERE DELIVERED. ALL ERRORS AND WARNINGS ARE TRIGGERED CORRECTLY BY THE PUMP. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    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 EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS SINCE (B)(6) 2013 UP TO 18-20 MMOL/L (324-360 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED TAKING CORRECTION VIA THE INFUSION DEVICE, AFTER THE ACCESSORIES WERE CHANGED AND AFTER CHANGING THE BASAL RATE; NO SUCCESS. PATIENT REPORTED THEN TAKING CORRECTION VIA THE PEN. PATIENT THINKS THE INFUSION DEVICE DELIVERY IS TOO LOW INSULIN. NO FURTHER INFORMATION IS AVAILABLE. 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
    194520 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR