BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6753303 · Received July 31, 2017

    Report

    Report Number
    2531779-2017-16529
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Report Date
    July 1, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1: DATE OF SUBMISSION 10/30/2017 - DEVICE EVALUATION: IN Q3 2017, THERE WERE 9 INSTANCES OF CS 052/053/054/055 SLEEP FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.

    Additional Manufacturer Narrative · 0

    OF THE 46 ALLEGATIONS OF A MALFUNCTION, 33 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 4 WERE FOUND TO BE MALFUNCTIONING DUE TO A TORN TRANSCEIVER FLEX CABLE. 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 46 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 5-74 YEARS OF AGE AND BETWEEN 23 AND 240 POUNDS. OF THE REPORTED PATIENTS, 22 WERE MALE, 24 WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535758 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1