BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241116 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49732
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE HAS BEEN RUNNING HIGH BLOOD GLUCOSE AND SHE DECIDED TO GO TO THE HOSPITAL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 234 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION WAS 269 MG/DL. CUSTOMER TOOK NUMEROUS BOLUSES WITH HER INSULIN PUMP. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. IT WAS FOUND DURING TROUBLESHOOT THAT THERE WAS ONE AIR BUBBLE NEAR THE TUBING. PERFORMED HIGH PRESSURE TEST AND TEST PASSED. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724235 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization