BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1399138 · Received June 3, 2009

    Report

    Report Number
    MW5011299
    Event Type
    Injury
    Date Received
    June 3, 2009
    Date of Event
    May 30, 2009
    Report Date
    June 3, 2009
    Manufacturer
    MEDTRONIC DIABETES
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MINIMED INSULIN PUMP MALFUNCTION. THE INDIVIDUAL NAMED IN THIS REPORT HAS BEEN WEARING AN INSULIN PUMP FROM MINIMED SINCE 1999. SHE HAS HAD TYPE 1 DIABETES FOR 45 YEARS. THIS IS THE SECOND PUMP ISSUED TO HER, AND WAS ISSUED APPROX FIVE YEARS AGO. THE INDIVIDUAL PERFORMED A ROUTINE CHANGE OF THE INFUSION SITE AND RE-LOADED THE DEVICE SYRINGE WITH SHORT-ACTING INSULIN AT APPROX 1830 HOURS. AT 1845 HOURS, SHE SHOWED CLEAR SIGNS OF HYPOGLYCEMIA. SHE WAS GIVEN CANDY TO ATTEMPT TO RAISE HER BLOOD SUGAR, BUT AFTER TEN MINUTES WAS MINIMALLY RESPONSIVE. EMS WAS CALLED AND THE PUMP WAS REMOVED. UPON ARRIVAL, EMS GAVE HER INJECTION OF D50, RESULTING IN RETURN OF NORMAL MENTAL STATUS. FINGERSTICK BLOOD GLUCOSE PERFORMED MY EMS UPON ARRIVAL WAS 14. ANALYSIS OF THE PUMP REVEALED APPROX 1 CC OF INSULIN HAD BEEN INJECTED IN A SHORT TIME. HOWEVER, THE INSULIN PUMP INTERNAL MEMORY SHOWED NO RECORD OF A BOLUS. THE DEVICE WAS REPLACED BY THE MANUFACTURER WITHIN 13 HOURS. HOWEVER, THE MANUFACTURER STATED THAT THE MALFUNCTIONING PUMP WOULD BE RECONDITIONED AND RETURNED TO THE INDIVIDUAL. IT HAS NOT YET ARRIVED. DATES OF USE: 2004 - 2009 - FIVE YEARS. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM LZG MEDTRONIC DIABETES

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| S