BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182521 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82195
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE FOR THE PAST SEVERAL HOURS. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 585MG/DL AND WAS TREATED WITH MANUAL INJECTIONS WHILE HE WAS CALLING. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER STATED THAT HE USES THE RESERVOIR FOR MORE THAN THREE DAYS. ADVISED THE CUSTOMER TO CHANGE THE RESERVOIR EVERY THREE DAYS. THE CUSTOMER CALLED BACK AND STATED THAT HE HAS CHANGED INSULIN, INFUSION SET, AND SITE AND HAS GIVEN MANUAL INJECTIONS, BUT HIS BLOOD GLUCOSE WAS NOT DROPPING. THE CUSTOMER STATED THAT HE IS GOING TO THE HOSPITAL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention