BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3180948 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08693
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    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 · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO LEAK WAS FOUND. OPEN PUMP TO INSPECT, NO DEFECT INVOLVING TO MOISTURE IN THIS PUMP. NO EVIDENCE OF INTERNAL MOISTURE IS FOUND. THE DISPLAY SCREEN IS TOTALLY BLANKED. OPEN PUMP TO INSPECT, REMOVE THE CRACKED DISPLAY SCREEN TO DO A TEST WITH KNEW GOOD SCREEN, THE GOOD DISPLAY SCREEN IS RESUME THE POWER UP AS NORMAL AND DISPLAY VERIFY SCREEN. 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 CRACKED AND BLANK 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
    279781 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR