BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2962249 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01807
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE UP AND DOWN ARROW BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE AND THE CONTRAST AND OK BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD WAS PEELING AND LIFTING FROM BELOW THE OK BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. EVALUATION REVEALED CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED/FADED DISPLAY SCREEN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE OK AND UP KEYPAD BUTTONS WERE NOT RESPONDING APPROPRIATELY TO PRESSES. THE PATIENT CONFIRMED THAT THERE WAS NO KNOWN DAMAGE TO THE KEYPAD. THIS ISSUE IS REPORTED BASED ON THE ALLEGATION THAT THE KEYPAD BUTTONS WERE NOT RESPONDING APPROPRIATELY TO PRESSES AND THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64979 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR