BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3112411 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06401
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. REPORTEDLY, THE OK BUTTON IS NOT RESPONDING CONSISTENTLY TO USER INPUT AND REQUIRES MULTIPLE PRESSES. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

    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: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING WAS OBSERVED. DURING TESTING, THE OK KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE UP ARROW, DOWN ARROW AND CONTRAST KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE DISPLAY WAS FADED, DISCOLORED AND DIFFICULT TO READ. A TEST SCREEN WAS INSERTED FOR THE INVESTIGATION AND WAS FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, 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. REPORTEDLY, THE OK BUTTON IS NOT RESPONDING CONSISTENTLY TO USER INPUT AND REQUIRES MULTIPLE PRESSES. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS NOT BEING REPORTED BECAUSE THE ISSUE OF WORN BUTTONS IS NOT LIKELY TO CAUSE AN ADVERSE EVENT AND THERE IS NO ISSUE WITH RESPONSIVENESS OF BUTTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212869 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR