BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2171112 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82123
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED UNEXPLAINED HIGH BLOOD GLUCOSE FOR THE PAST DAY. THE CUSTOMER GLUCOSE READING AT TIME OF CALL WAS 481MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. WHILE THE CUSTOMER WAS ON THE PHONE, SHE BECAME ILL AND STARTED VOMITING. A CUSTOMER'S FAMILY MEMBER PICKED UP THE PHONE AND STATED GOING TO TAKE CUSTOMER TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE. ADVISED THE FAMILY MEMBER TO HAVE THE CUSTOMER DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. IT WAS STATED THAT THE CUSTOMER INSERTED HER INFUSION SET THE NIGHT BEFORE. IT WAS STATED THAT THE CUSTOMER DOES NOT HAVE A SITE ROTATION METHOD. EXPLAINED ROTATION METHOD OPTIONS FOR ABDOMEN. NO FURTHER INFORMATION 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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention (B)(4) INFUSION SET: MMT-397| PARADIGM, 9M CATHETER| QUICK-SET, 23