BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4212146 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30807
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 23-MAY-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, NO DAMAGE OR PEELING WAS FOUND TO THE KEYPAD. ALL KEYS WERE RESPONSIVE TO USER INPUT. THE KEYPAD WAS REMOVED, AND NO EVIDENCE OF CONTAMINATION WAS FOUND ON THE BUTTON CONTACTS. THE PUMP WAS OPENED, AND NO EVIDENCE OF MOISTURE CORROSION WAS FOUND NEAR THE KEYPAD CONNECTOR. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND PINK, AND THE BATTERY COMPARTMENT WAS CRACKED FROM THE TOP TO THE COVER PART. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692368 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR