BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090156 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81362
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER HAD LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 47MG/DL. IT WAS STATED THAT THE CUSTOMER WAS GIVEN SODA, AND HIS BLOOD GLUCOSE CAME UP TO 112MG/DL. IT WAS STATED THAT THE CUSTOMER'S WIFE CALLED TO PARAMEDICS. IT WAS STATED THAT THE CUSTOMER DECLINED TO BE TAKEN TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS FINE. IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED DURING MANUAL PRIME. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP PASSED. IT WAS STATED THAT THE CUSTOMER BOLUSED A COUPLE EXTRA TIMES THE DAY BEFORE THE EVENT, WHICH MAY HAVE CAUSED HIS LOW BLOOD GLUCOSE. 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 32 YR Required Intervention