BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931562 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01242
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 03/22/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE AUDIO BOLUS BUTTON WAS FULLY INTACT. DURING TESTING, THE AUDIO BOLUS BUTTON RESPONDED APPROPRIATELY; THE COMPLAINT COULD NOT BE DUPLICATED. DURING INVESTIGATION, THE BUTTON COVER WAS REMOVED AND NO CONTAMINATION OR DAMAGE WAS FOUND. UNRELATED TO THE COMPLAINT, THE KEYPAD RUBBER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE KEYPAD BUTTON CONTACTS. 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 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE AUDIO BOLUS BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE PATIENT CONFIRMED THAT THE AUDIO BOLUS BUTTON WAS INTACT. THE PATIENT STATED THAT THERE WAS NO MOISTURE TO THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36946 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR