BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2993595 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02491
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PRIME HISTORY SHOWED LARGE PRIME VOLUME AMOUNTS ON THE REPORTED FAILURE DATE. THE BLACK BOX REVIEW SHOWED MULTIPLE OCCLUSION ALARMS. THE PUMP POWERED ON NORMALLY DURING LOAD STEP ATTEMPT, THE PISTON STOPPED AT 205 UNITS. INVESTIGATORS WERE ABLE TO PRIME THE PUMP AND OCCLUSION ALARM WAS DUPLICATED UPON THE FIRST BASAL PROGRAM DELIVERY ATTEMPT. THE FORCE SENSOR CALIBRATION READING IS ABOVE SPECIFICATIONS. THE PUMP WAS OPENED AND INSPECTED, A SINGLE COMPONENT WAS FOUND TO BE MISALIGNED ON THE PCB. THE FORCE SENSOR RESISTANCE READING IS WITHIN NORMAL SPECIFICATIONS. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT A SINGLE COMPONENT ON THE PCB WAS FOUND TO BE MISALIGNED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98255 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR