BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183102 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40091
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 591 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER COULD NOT GET OUT OF BED, FELT SICK, SEIZED AT THE HANDS AND ARMS, COULD NOT SEE WITH OPEN EYES, AND HAD DIFFICULTY BREATHING; HER CONDITION DID NOT IMPROVE AFTER BOLUSING AND MANUAL INJECTIONS, WHICH LED TO THE 911 CALL. PARAMEDICS TOOK THE CUSTOMER OFF INSULIN PUMP THERAPY UPON ARRIVAL. THE CALLER OBSERVED AIR BUBBLES IN THE TUBING OF THE INFUSION SET. UPON TROUBLESHOOTING THE INSULIN PUMP, IT WAS FOUND THAT THE DEVICE WAS WORKING AS DESIGNED. THE CALLER STATED THAT COLD INSULIN WAS BEING USED; ADVISED AGAINST THIS AND RECOMMENDED USE OF ROOM TEMPERATURE INSULIN. THE CUSTOMER WAS TREATED AT THE HOSPITAL AND DISCHARGED. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660086 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization