BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED PARADIGM

    MDR report key: 3193579 · Received June 23, 2013

    Report

    Report Number
    MW5030681
    Event Type
    Injury
    Date Received
    June 23, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 23, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A MEDTRONIC MINIMED PARADIGM INSULIN PUMP - REF MMT 722NAL, SN (B)(4), CONF F759 AND HAVE BEEN CONCERNED ABOUT THE LACK OF AN ALARM WHEN INSULIN IS COMPLETELY GONE. THERE HAVE BEEN MAYBE HALF A DOZEN TIMES IN THE LAST 3 YEARS. MOST RECENTLY I THINK ON (B)(6) 2013, SINCE I HAVE HAD THIS PUMP WHEN I HAVE COMPLETELY RUN OUT OF INSULIN. IT GAVE ME A WARNING WHEN I HAD 20 UNITS REMAINING AND ANOTHER ALARM WHEN THERE WERE 10 UNITS REMAINING. AFTER THAT, THERE ARE NO FURTHER ALARMS AS IT GOES TO ZERO AND THEN IS DELIVERING NO INSULIN AT ALL. SOMETIMES, I HAVE BEEN BUSY WHEN I GET THOSE INITIAL ALARMS AND HAVE NOT IMMEDIATELY TAKEN ACTION TO CHANGE MY INFUSION SET AND RELOAD INSULIN. WHEN I FINALLY REMEMBER, I NOTICE THAT THERE IS NO INSULIN DELIVERY AND I AM NOT SURE HOW LONG I HAVE BEEN WITHOUT INSULIN. I HAVE NEVER HAD A CRISIS, BUT THIS SEEMS LIKE IT COULD BE A MAJOR EMERGENCY IF IT HAPPENS OVERNIGHT OR WHEN A PERSON MIGHT NOT NOTICE FOR AN EXTENDED PERIOD OF TIME. I PREVIOUSLY HAD AN OLDER MODEL OF A MINIMED PUMP 508, I THINK. IT HAVE ME AN ALARM WHEN THE INSULIN WAS LOW, BUT THEN IF IT WAS COMPLETELY GONE, THERE WAS A LOUDER AND CONTINUOUS ALARM THAT WAS DIFFICULT OR IMPOSSIBLE TO IGNORE AND IT DID NOT STOP UNTIL I CHANGED THE INFUSION SET AND ADDED INSULIN. WHEN I ASKED THE MEDTRONIC HELPLINE, THEY REACTED LIKE THE 10 AND 20 UNIT ALARMS SHOULD BE SUFFICIENT AND DID NOT GIVE ME A SATISFACTORY RESPONSE. THEY ALSO DID NOT GIVE ME A SATISFACTORY RESPONSE WHEN I SAID THEIR OLD MODEL HAD A LOUD ALARM WHEN INSULIN WAS GONE, BUT THIS NEWER MODEL DID NOT. WHEN I MENTIONED IT TO MY DIABETES EDUCATOR THIS YEAR, SHE WAS NOT AWARE OF THIS PROBLEM. I HAVE JUST COPED WITH THIS DEFICIENCY, BUT FINALLY DECIDED I SHOULD MAKE YOU AWARE OF IT, BEFORE THERE ARE ANY BAD OUTCOMES FOR ME OR SOMEONE ELSE. I THINK THERE SHOULD BE A FAIL-SAFE ALARM THAT PREVENTS THIS PROBLEM. DIAGNOSIS OR REASON FOR USE: TYPE I DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284606 MEDTRONIC MINIMED PARADIGM INSULIN PUMP OYC MEDTRONIC MINIMED MMT 722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R