BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6085385 · Received November 8, 2016

    Report

    Report Number
    2531779-2016-30832
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. FOLLOW-UP #1 DATE OF SUBMISSION 11/14/2016-CORRECTION TO SERIAL #, BRAND NAME, MODEL #, & PMA/510(K)#.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 500 MG/DL WITH SYMPTOMS OF THIRST, NAUSEA, VOMITING, AND MODERATE KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE PATIENT HAD REMAINED ON THE PUMP AT THE TIME OF THE CALL. THE REPORTER WAS UNABLE TO TROUBLESHOOT THE PUMP AT THE TIME OF THE CALL. THE REPORTER STATED THAT THE PUMP'S BASAL AND BOLUS SETTINGS HAD BEEN CHANGED BY THE PATIENT'S HEALTHCARE PROVIDER IN RELATION TO THE BLOOD GLUCOSE EXCURSION. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT HAD A HYPERGLYCEMIC EVENT WHILE ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737942 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening