BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3111263 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06292
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS:TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION. PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO ALARMS. PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE. THE BATTERY WAS REMOVED FOR ABOUT 6 HOUR AND REINSERTED, THE PUMP TIME AND DATE DID RESET TO THE DEFAULT SETTINGS. PUMP WAS OPEN TO INVESTIGATE, COMPONENT BT1 WAS FOUND TO BE LEAKING. BLACK BOX INDICATES A TIME AND DATE RESET IN WITHIN 13 HOURS, 47 MINUTES OF POWER OFF. UNRELATED TO THE COMPLAINT, PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. PUMP COVER WAS REMOVED AND THE OLED SCREEN WAS REMOVED AND REPLACED WITH A NEW TEST SCREEN, CONTRAST RETURNED TO NORMAL WITH TEST SCREEN. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A LEAKING INTERNAL BATTERY AND A DIM DISPLAY SCREEN. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212182 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR