BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183580 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40361
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO 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

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 491 MG/DL. HE STATED HE HAD SWITCHED OUT THE INSULIN BELIEVING THAT WAS THE CAUSE OF HIS HIGH BLOOD GLUCOSE. THE CUSTOMER STATED HE HAD A PREVIOUS HIGH BLOOD GLUCOSE INCIDENT DUE TO BAD INSULIN. HE ALSO REPORTED A KINKED/BENT INFUSION SET. THE CUSTOMER HAS ATTEMPTED TO TREAT HIS HIGH BLOOD GLUCOSE WITH 10 UNITS OF INSULIN FROM THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED SYMPTOMS OF HIGH BLOOD GLUCOSE SUCH AS NAUSEA, HEADACHE, AND CONFUSION. THE CUSTOMER STATED HIS BLOOD GLUCOSE HAD DECLINED TO 411 MG/DL. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT FROM THE TUBING AND THERE WAS NO LEAK PRESENT ON THE INSULIN PUMP. THE CUSTOMER ALSO STATED THE DOCTOR HAD RECENTLY CHANGED HIS SETTINGS. HE WAS ADVISED THE CHANGES TO HIS SETTINGS MAY CAUSE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO CHANGE OUT HIS INFUSION SET, RESERVOIR, AND INSULIN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664053 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR