BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6511334 · Received April 21, 2017

    Report

    Report Number
    2531779-2017-08272
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Report Date
    March 31, 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

    OF THE 42 ALLEGATIONS OF A MALFUNCTION, 30 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 1 WAS FOUND TO BE MALFUNCTIONING DUE TO A CALL SERVICE ALARM ISSUE. 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 42 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 49-228 POUNDS AND BETWEEN 5 AND 80 YEARS OF AGE. OF THE REPORTED PATIENTS, 18 WERE MALE, 23 WERE FEMALE, AND 1 WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 07/29/2017. DEVICE EVALUATION: IN Q2 2017, THERE WERE 8 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 227 PILOT PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294644 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1