BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2201114 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05788
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(6) 2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS WERE RESPONDING PROPERLY WITH THE EXCEPTION OF THE CONTRAST AND UP ARROW BUTTONS. THE CONTRAST AND UP ARROW BUTTONS WERE INOPERABLE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL CONTACTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY CAP THREADS WERE NOTED TO BE STRIPPED AND UNABLE TO SECURE. THE TESTING WAS PERFORMED WITH A TEST BATTERY CAP WHICH WAS ABLE TO SECURE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK KEYPAD BUTTON HAS BEEN FLAT AND DIFFICULT TO PRESS FOR THE PAST TWO MONTHS. SHE STATED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS STILL FUNCTION APPROPRIATELY. SHE STATED THAT THE KEYPAD BUTTON SYMBOLS ARE WORN BUT THE KEYPAD IS INTACT. THE PATIENT STATED THAT SHE WEARS THE PUMP UNDER HER CLOTHING AND DOES NOT CLEAN THE PUMP.

    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 36 YR