BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2994211 · Received March 8, 2013

    Report

    Report Number
    2531779-2013-02490
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FILL TEST, AND A FORCE TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACK BOX SHOWED MULTIPLE OCCLUSION ALARMS ON THE REPORTED FAILURE DATE. 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 ,WAS UNABLE TO RUN THE UNIT FOR 24 HOURS. THE FORCE SENSOR CALIBRATION READING FAILED WITH THE HIGHEST COUNT SPECIFICATION. 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).

    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
    98997 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR