BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3813464 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13727
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    September 16, 2025
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2014 WITH THE FOLLOWING FINDINGS:A PORTION OF THE KEYPAD WAS FOUND TO BE MISSING. EVALUATION REVEALED THE DOWN KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. THE DOWN BUTTON CONTACT WAS FOUND TO BE INVERTED. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. A BATTERY COMPARTMENT CRACK WAS OBSERVED DURING EVALUATION. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE, KEYPAD DAMAGE AND RESPONSE ISSUE, AND CASE DAMAGE ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 05/06/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292046 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female