BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3043535 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03857
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    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

    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. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP # 1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED THE OK BUTTON RESPONDS TO PRESSES INTERMITTENTLY; ALL OTHER BUTTONS RESPOND TO PRESSES APPROPRIATELY. THE KEYPAD WAS UNDAMAGED AND WAS REMOVED; NO DAMAGED/MISALIGNED CONTACTS FOUND, CONTAMINATION FOUND UNDER ALL 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.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE OK KEYPAD BUTTON IS UNRESPONSIVE. 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
    146809 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1