BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 7376340 · Received March 27, 2018

    Report

    Report Number
    2531779-2018-06265
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF SUBMISSION 09-APR-2018 SERIAL #(B)(4), BRAND NAME ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM, MODEL # ONE TOUCH PING INSULIN PUMP, & G5 PMA/510(K)# K080639.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE AND THE PUMP MODEL WAS NOT SPECIFIED; IF FURTHER INFORMATION IS PROVIDED, A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216078 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR