BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1963501 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00168
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DUPLICATED DURING TESTING. INVESTIGATION REVEALED A DISLODGED DISPLAY SCREEN AND FULLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE RECEIVED A LOSS OF PRIME WARNING ON HIS PUMP. HE STATED THAT HE DISCONNECTED FROM THE INFUSION SITE, COMPLETED THE REWIND STEP, AND THEN THE PISTON ROD DID NOT STOP DURING THE LOAD CARTRIDGE PHASE. THE CARTRIDGE WAS EMPTIED OF INSULIN. THE PT REPORTED THAT HE FILLED ANOTHER CARTRIDGE WITH INSULIN AND WAS ABLE TO SUCCESSFULLY REWIND/LOAD/PRIME PUMP, BUT IMMEDIATELY RECEIVED ANOTHER LOSS OF PRIME WARNING.

    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 45 YR