BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1874127 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01655
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP IS NOT RESPONDING WHEN THE DOWN ARROW IS PRESSED. THE PATIENT INDICATED THAT SHE IS STILL ABLE TO BOLUS BECAUSE THE UP ARROW AND THE OK BUTTONS ARE WORKING. SHE INDICATED THAT THE BUTTONS DO NOT CLICK/SPRING BACK. SHE DENIED GETTING THE PUMP WET AND STATED THAT THERE IS NO TRAUMA TO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1