BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130968 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27989
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 12/02/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN; HOWEVER, THERE WAS NO EVIDENCE OF PEELING OR TEARING OBSERVED. THE COMPLAINT THAT THE UP ARROW KEYPAD BUTTON WAS UNRESPONSIVE WAS NOT ABLE TO BE DUPLICATED DURING TESTING. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE UP ARROW, DOWN ARROW, AND CONTRAST BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE PUMP¿S VIBRATION FEATURE WAS NOT FUNCTIONING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW KEYPAD BUTTON WAS UNDER RESPONSIVE. 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
    609369 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR