BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3842215 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15378
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND THERE WAS CONTAMINATION OBSERVED UNDER ALL OF THE BUTTON CONTACTS. FURTHER TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE UNRESPONSIVE KEYPAD BUTTONS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A DIM, DISCOLORED DISPLAY AND MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. 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

    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
    320538 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR