BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 7457888 · Received April 25, 2018

    Report

    Report Number
    2531779-2018-07938
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Report Date
    March 31, 2018
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    OF THE 56 ALLEGATIONS OF A MALFUNCTION, 43 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 7 WERE FOUND TO BE MALFUNCTIONING DUE TO A SINGLE COMPONENT FAILURE. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 56 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A CS 052/053/054/055 SLEEP ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 10-74 YEARS OF AGE AND BETWEEN 55 AND 228 POUNDS. OF THE REPORTED PATIENTS, 29 WERE MALE, 26 WERE FEMALE, AND 1 WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: IN QUARTER 2 OF 2018, THERE WERE 1 INSTANCES OF CS 052/053/054/055 SLEEP FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER (B)(4). THIS MDR REPORT IS PART OF THE (B)(4) PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305511 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1