BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED PARADIGM523

    MDR report key: 3170020 · Received June 10, 2013

    Report

    Report Number
    MW5030531
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIX MONTH OLD MEDTRONIC INSULIN PUMP, NOTICED A CRACK ON THE SEAM, BELOW THE WINDOW THAT SHOWS THE SYRINGE. DID NOT DROP THE PUMP, BEEN ON ONE FOR MORE THAN 30 YRS, KNOW HOW TO TAKE CARE OF THEM. DO NOT HAVE THE SERIAL NUMBER, ALREADY RETURNED. PUMP WAS 6 MONTHS OLD. UNDER WARRANTY, BUT I DID NOT GET A NEW PUMP IN RETURN. THEY SENT ME A RECONDITIONED PUMP WITH A NEW CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261716 MEDTRONIC MINIMED PARADIGM523 NONE LZG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention MEDTRONIC MINIMED INSULIN PUMP| HUMALOG INSULIN U-100