BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2981812 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02233
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 19, 2013
    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. 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 12/04/2015: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/16/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY FOUND NO INDICATION OF A TIME LOSS/GAIN ISSUE. THE PUMP MAINTAINED TIME AND DATE ACCURATELY DURING A TIME KEEPING ACCURACY TEST. THERE WERE NO ERRORS, ALARMS, OR WARNINGS THAT OCCURRED DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PUMP'S TIME LAG WAS ABOUT SEVEN MINUTES WHEN BATTERY WAS CHANGED. THE PATIENT STATED THIS LAG TIME ISSUE STARTED ONE YEAR AGO BUT DID NOT WANT TO REPORT IT THEN. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE TIME LOSS/GAIN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83359 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR