BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 3012056 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00432
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 30, 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 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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED. RESULT THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEETS THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE IU INVESTIGATION. HISTORY LIST: THE CUSTOMER GAVE LESS BOLUSES VIA THE PUMP AT THE (B)(6) 2013. AT THIS DAY THE PUMP ONLY DELIVERED THE BASAL RATE AND ONE BOLUS OF 9.0 IU. ON (B)(6) 2013, 11:59 THE CUSTOMER STOPPED USING THE PUMP. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL WENT FROM 186 TO 260 MG/DL. THE PATIENT CHANGED THE INFUSION DEVICE'S ACCESSORIES, BUT HIS BLOOD GLUCOSE LEVEL REMAINED ELEVATED. THE PATIENT SWITCHED TO HIS BACKUP DEVICE AND HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. HE THINKS HIS PRIMARY DEVICE DELIVERS TOO LOW AN AMOUNT OF INSULIN. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115394 ACCU-CHEK D-TRONPLUS INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR