BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 117004 · Received August 29, 1997

    Report

    Report Number
    2025512-1997-00078
    Event Type
    Malfunction
    Date Received
    August 29, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 23, 1997
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED UNIT WAS NOT DELIVERING PROPERLY AND BG'S WERE ELEVATED. WAS ADVISED BY PHYSICIAN TO TAKE MANUAL INJECTION TO STABILIZE BG'S. IT WAS NOTED THAT THE DRIVER BLOCK SLID UP AND DOWN THE LEADSCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-504S *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR