BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3022874 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03130
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS FULLY INTACT; THERE WAS NO PEELING OR DAMAGE WAS OBSERVED. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. THE UP AND DOWN KEYS ARE INTERMITTENTLY UNRESPONSIVE AND REQUIRE EXCESSIVE FORCE TO ACTIVATE. THE OK AND CONTRAST KEYS RESPOND APPROPRIATELY. INVESTIGATORS REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH NEW TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST AND NO INDICATION OF DISCOLORATION. THE KEYPAD COVER WAS REMOVED TO FURTHER INVESTIGATE; CONTAMINATION WAS FOUND UNDER THE ALL KEY CONTACTS.

    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 CHANGES/UNRESPONSIVE) ISSUE WITH THE DOWN ARROW BUTTON. THE PATIENT REPORTEDLY WORE THE PUMP EXTERIOR TO A GARMENT AND CLEAN THE PUMP WITH A WASHCLOTH AND SOAPY WATER. 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
    126328 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR