BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6987500 · Received October 30, 2017

    Report

    Report Number
    2531779-2017-25309
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    October 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
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1: DATE OF SUBMISSION 30-JAN-2018 - DEVICE EVALUATION: IN Q4 2017, THERE WERE 3 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 · 1

    OF THE 143 ALLEGATIONS OF A MALFUNCTION, 61 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 44 WERE FOUND TO BE MALFUNCTIONING DUE TO CORRUPTED SOFTWARE AND THE CONTINUOUS-GLUCOSE-MONITOR TRANSCEIVER FLEX CABLE-CONNECTOR WAS DEFECTIVE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 92 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A CALL-SERVICE ALARM CS 052/053/054/055 SLEEP ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 4-70 YEARS OF AGE AND BETWEEN 20 AND 300 POUNDS. OF THE REPORTED PATIENTS, 35 WERE MALE, 57 WERE FEMALE, AND 0 WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767884 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1