BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2771558 · Received October 4, 2012

    Report

    Report Number
    2531779-2012-11767
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 05/14/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, DURING TESTING THE PUMP VIBRATION WAS FOUND TO BE INOPERABLE; THE PUMP WAS OPENED AND FOUND THAT THE VIBRATION MOTOR HAD FAILED.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 AND STATED THE OK, UP AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE REPORTER DENIED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP EXTERIOR TO A GARMENT AND DID NOT CLEAN IT. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR