BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3162200 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08069
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE KEYPAD ISSUE, EVALUATION REVEALED EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. THE CARTRIDGE COMPARTMENT WAS CRACKED AT THE OPENING OF THE CARTRIDGE CHAMBER. THERE WAS NO EVIDENCE OF MOISTURE DAMAGE IN THE CARTRIDGE COMPARTMENT. ALSO UNRELATED TO THE KEYPAD COMPLAINT, THE RETURNED BATTERY CAP WAS DAMAGED AND UNABLE TO FULLY TIGHTEN IN THE PUMP. THE BATTERY CAP THREADS WERE STRIPPED; PART OF THE BATTERY CAP WAS BROKEN OFF AT THE RIM OF THE CAP. A TEST CAP WAS ABLE TO FULLY TIGHTEN INTO THE RETURNED PUMP WITH NO POWER REBOOTS OCCURRING. THE RETURNED BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND TO BE WITHIN SPECIFICATIONS. DURING TESTING, THE PUMP SUCCESSFULLY PASSED THE LEAK TEST. THE PUMP WAS OPENED AND NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. 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)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER STATED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE INTERMITTENTLY 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
    262768 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR