BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873345 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85776
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT HE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OVER THE WEEKEND AND AFTER HAVING BREAKFAST, LEVELS QUICKLY INCREASED. BLOOD GLUCOSE LEVEL AT 583 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER ADVISED TO DISCONNECT FROM PUMP. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN EXITED TUBING. INSULIN PUMP DID NOT ALARM AND CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY. CUSTOMER WAS ASKED TO REMOVE INFUSION SET AND FOUND CANNULA WAS BENT. INFORMED CUSTOMER HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INSERTION SITE ISSUES. BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349091 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 10 YR Hospitalization