BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974463 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02041
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/22/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE KEYPAD COVER WAS INTACT; NO DAMAGE WAS OBSERVED. THE AUDIO BOLUS BUTTON COVER WAS FOUND TO BE TORN AND THE BUTTON CONTACT WAS MISSING. THE UP ARROW, DOWN ARROW, OK AND CONTRAST KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE. THE AUDIO BOLUS BUTTON WAS NOT ABLE TO BE TESTED DUE TO THE BUTTON DAMAGE. THE KEYPAD COVER WAS REMOVED AND THE KEYPAD FLEX WAS OBSERVED TO BE TORN. THERE WAS EVIDENCE OF MOISTURE FOUND ON THE KEYPAD FLEX CONNECTOR AND INSIDE THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. IT WAS REPORTED THAT THE AUDIO BOLUS BUTTON REQUIRED HARD PRESSES TO ELICIT A RESPONSE AND THE COVERING OF THE BUTTON WAS MISSING. REPORTEDLY, THE TACTILE CHANGES HAD OCCURRED PRIOR TO THE DAMAGE TO THE RUBBER BUTTON. 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
    78592 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR