BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960749 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21568
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP HISTORIES SHOWED THAT THE PUMP WAS NOT IN USE BEYOND(B)(4) 2014. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS IN THE 400'S MG/DL WITH NAUSEA AND NO REPORTED KETONES. REPORTEDLY, THE PATIENT HAD NOT HAD ANY PUMP SETTING ADJUSTMENTS BEFORE OR AFTER THE ALLEGED EVENT AND HAD NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND USUAL DIABETES MANAGEMENT. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF THE INITIAL CALL. THE ALLEGED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED INACCURATE DELIVERY ISSUE WHERE A PUMP MALFUNCTION COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438168 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR