BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132384 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07176
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 07/24/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS:TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'OK','UP','DOWN' AND 'CONTRAST' BUTTONS. NO VISIBLE DAMAGE ON THE KEYPAD. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THIS COMPLAINT, OBSERVED THE BATTERY COMPARTMENT IS CRACKED AT OPENING OF BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. A TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. THERE WAS NO POWER LOSS OR MOISTURE ISSUE EVIDENT.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE OK KEYPAD BUTTON WAS NOT WORKING PROPERLY. 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
    234879 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR