BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2010318 · Received February 11, 2011

    Report

    Report Number
    2531779-2011-00779
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. THE LOSS OF DETECTION WAS ALSO DUPLICATED DURING TESTING. INVESTIGATION REVEALED A DISLODGED DISPLAY SCREEN AND FULLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE PHASE. THE PT REPORTED THAT HE RECEIVED MULTIPLE LOSS OF PRIME WARNINGS. HE ATTEMPTED TO RE-PRIME THE PUMP BUT THE ALARM REPEATED WITH EACH ATTEMPT. THE PT STATED THAT THE LOSS OF PRIMES WERE NOT ASSOCIATED WITH A BATTERY OR CARTRIDGE REPLACEMENT, THE CARTRIDGE CAP WAS SECURE, THERE WERE NO ASSOCIATED ALARMS, AND THERE WAS NO EXPOSURE TO EXTREME TEMPERATURES. THE PT WAS ADVISED TO CHANGE THE CARTRIDGE AND HE STATED THAT WHEN HE DID SO THE PUMP EMPTIED THE CARTRIDGE DURING THE LOAD CARTRIDGE PHASE OF THE PROCESS. HE CONFIRMED THAT HE WAS DISCONNECTED FROM THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR