BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1010124 · Received March 10, 2008

    Report

    Report Number
    2531779-2008-00129
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 4, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DAMAGED FORCE SENSOR. THE PT WAS CONNECTED TO THE INFUSION SET DURING THE REWIND AND LOAD CARTRIDGE PROCESS. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE SET PRIOR TO INITIATING THE PRIME / REWIND SEQUENCE. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE REWIND / LOAD CARTRIDGE / PRIME SEQUENCE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE PRIMED THE PUMP WHILE ATTACHED TO THE INFUSION SET AND THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP. THE PT EXPERIENCED HYPOGLYCEMIA BUT NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200

    Patients

    Seq Age Sex Outcome Treatment
    1