BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4250141 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32649
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/06/2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. REVIEW OF ALARM HISTORY SHOWS ONE OCCLUSION ALARM ON (B)(6) 2014. PUMP WAS EXERCISED FOR 24-HRS ON WITH NO ¿OCCLUSION¿ ALARMS DUPLICATED. PUMP WAS MANUALLY OCCLUDED DURING TESTING AND DISPLAYED AN "OCCLUSION ALARM" MESSAGE ON THE SCREEN ALONG WITH VIBRATE AND AUDIBLE FEATURES OCCLUSION FEATURE FOUND TO BE FUNCTIONING PROPERLY. FORCE SENSOR TEST VERIFIES FORCE SENSOR DETECTING CORRECT FORCE AT 5 LBS. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. PUMP PASSED FLOW ACCURACY TESTING AND 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP HAD FAILED TO EMIT AN OCCLUSION ALARM AND THE PATIENT HAS A BLOOD GLUCOSE GREATER THAN 500 MG/DL. THE PATIENT HAS LOST CONFIDENCE IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALARM ISSUE WAS NOT RESOLVED AND THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736715 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening