BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2220598 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06121
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/26/2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION CONFIRMED THAT THE KEYPAD BUTTON COVER WAS INTACT TO THE BASE WITH NO EVIDENCE OF PEELING. TESTING CONFIRMED THAT ALL KEYPAD BUTTONS WERE RESPONSIVE AS NORMAL. CONTAMINATION WAS VISIBLE UNDERNEATH ALL OF THE KEY CONTACTS. UNRELATED TO THE KEYPAD ISSUE, THE DISPLAY SCREEN HAD DIM PINK AND FADING LETTERING. 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. 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.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE OK BUTTON REQUIRED TWO PRESSES BEFORE THE BOLUS DOSE WAS CANCELLED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 7 YR