BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3970392 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21918
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE UP, DOWN, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BOLUS BUTTON COVER WAS DISCOVERED TO BE TORN; THE BOLUS BUTTON WAS FOUND TO BE APPROPRIATELY RESPONSIVE. A BATTERY COMPARTMENT CRACK WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. 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
    448037 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR