BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1030020 · Received April 14, 2008

    Report

    Report Number
    2531779-2008-00207
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A VISIBLE CRACK IN THE BATTERY COMPARTMENT CONSISTENT WITH THE PATIENT'S REPORT. EVALUATION ALSO REVEALED A DAMAGED BATTERY CAP THAT COULD NOT BE PROPERLY ATTACHED. THE PUP USER GUIDE INSTRUCTS THAT THE BATTERY CAP MUST BE REPLACED A MINIMUM OF ONCE PER YEAR. THERE IS NO EVIDENCE THAT THE BATTERY CAP WAS REPLACED BY THE USER. THE PUMP WAS EVALUATED USING A REPLACEMENT BATTERY CAP AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED EMERGENCY ROOM TREATMENT FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT ALSO REPORTED, THAT THE PUMP EXHIBITED A VISIBLE CRACK IN THE BATTERY COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization