BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2072962 · Received April 13, 2011

    Report

    Report Number
    2531779-2011-02718
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIME ON THE PUMP WAS FIVE HOURS BEHIND THE CORRECT TIME. A FAMILY MEMBER NOTED THAT HE NOTICED THAT THE PT'S BLOOD GLUCOSE WAS LOWER THAN USUAL AROUND DINNER TIME. HE REPORTED THE BLOOD GLUCOSE WAS 60-70 MG/DL WITHOUT SYMPTOMS OF HYPOGLYCEMIA. THE FAMILY MEMBER STATED THAT THREE DAYS LATER, HE NOTICED THAT THE TIME WAS INCORRECT. THERE WAS NO CONFIRMATION OF WHEN THE TIME RESET HAD OCCURRED. THE FAMILY MEMBER STATED THAT HE CORRECTED THE TIME AND HAS HAD NO FURTHER PROBLEMS WITH THE CLOCK SINCE THAT TIME.

    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 15 YR