BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 377448 · Received February 18, 2002

    Report

    Report Number
    2032227-2002-00022
    Event Type
    Malfunction
    Date Received
    February 18, 2002
    Date of Event
    December 12, 2001
    Report Date
    December 12, 2001
    Manufacturer
    MEDTRONIC MINIMED INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HAVING AN EXCESSIVE AMOUNT OF "NO DELIVERY" ALARMS. IT WAS STATED THAT THE DEVICE ALARMED FOR NO DELIVERY EVEN WITH THE RESERVOIR REMOVED. AN ATTEMPT WAS MADE TO TEST THE ROTATION OF THE LEADSCREW BUT AGAIN THE NO DELIVERY ALARM WAS ACTIVATED. IT WAS INDICATED THAT THE DEVICE HAD NOT BEEN DROPPED, BUMPED, OR EXPOSED TO ANY MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MEDTRONIC MINIMED INC. MMT-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR