BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1843755 · Received September 10, 2010

    Report

    Report Number
    2531779-2010-01224
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. EVAL FOUND THAT THE PUMP POWERS UP PROPERLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OR RE-BOOTS OCCURRING. NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. RE-BOOTS WERE OBSERVED IN THE PUMP HISTORY, BUT WERE NOT DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP RE-BOOTED WITHOUT USER INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR