BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090922 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01106
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 668 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER STATED THAT HE WOKE UP WITH ACHING MUSCLES. THE CUSTOMER DELIVERED BOLUSES AND CHANGED THE INFUSION SET, BUT CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVELS CAME DOWN AFTER DELIVERING A MANUAL INJECTION. THE CUSTOMER STATED THAT THE CANNULAS WERE BENT IN THREE PLACES WHEN REMOVED. THE CUSTOMER USES THE MIO, MMT-975, LOT#3700039. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-723PNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization MODEL MMT-975, LOT# 3700039| (B)(4) MIO PARADIGM INSULIN INFUSION SET: