BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2934863 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01346
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 03/19/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED THE DOWN AND UP KEYS ARE INTERMITTENTLY RESPONDING TO USER INPUT AND REQUIRE EXCESSIVE FORCE TO ACTIVATE. CONTAMINATION WAS FOUND UNDER THE UP, DOWN AND CONTRAST KEY CONTACTS. UNRELATED TO THIS COMPLAINT, THE BLACK BOX SHOWS EVIDENCE OF TIME AND DATE RESETTING TO THE DEFAULT AFTER POWER ON RESETS ON 01/19/2013. REMOVAL OF THE PUMP COVER AND A VISIBLE INSPECTION CONFIRMED THE INTERNAL BATTERY WAS LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THE DOWN ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ENGAGE. 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
    41351 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR