BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2171129 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01703
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NOT PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST DAY. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE READING WAS 328 MG/DL. THE CUSTOMER STATED THAT SHE WAS RECENTLY PUT ON MEDICATION THAT MIGHT CAUSE ELEVATED BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. DURING THE HIGH PRESSURE TEST, THE CUSTOMER BEGAN EXPERIENCING INTENSE CHEST PAIN. THE PARAMEDICS WERE CALLED, AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL, WHERE SHE WAS KEPT FOR OBSERVATION AND TESTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization MMT-397, LOT 9202086.| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET