BEUDAMED
    FDA Adverse Event Summary report: N

    MINI-MED 507

    MDR report key: 476361 · Received July 21, 2003

    Report

    Report Number
    MW4003550
    Date Received
    July 21, 2003
    Report Date
    June 19, 2003
    Manufacturer
    MEDTRONIC MINIMED INC.
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PUMPS WERE NOT FUNCTIONING NORMALLY, UNSTABLE AND UNRELIABLE. REPORTER STATES THAT IN THE PAST 12 MONTHS, IN THEIR PRACTICE, 4 SEPARATE PUMPS HAVE HAD BREAKDOWNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-MED 507 INSULIN PUMP LZG MEDTRONIC MINIMED INC. 507 *
    2 MINI-MED 508 INSULIN PUMP LZG MEDTRONIC MINIMED INC. 508 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *