BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3915338 · Received July 7, 2014

    Report

    Report Number
    2531779-2014-19189
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/06/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS FOUND TO THE KEYPAD COVER. DURING TESTING, ALL OF THE KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED, AND CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS. THE DOWN ARROW BUTTON CONTACT WAS ALSO DAMAGED AND DIDN¿T SPRING BACK AFTER BEING PRESSED. ADDITIONALLY, THE BOLUS BUTTON COVER WAS TORN; THE BUTTON RESPONDED PROPERLY. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. ADDITIONALLY, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A KEYPAD BUTTON RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394231 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR