BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2190324 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82235
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED TWICE THROUGHOUT THE DAY DUE TO HIGH BLOOD GLUCOSE AND KETONES. THE BLOOD GLUCOSE READING WAS 400MG/DL THE FIRST TIME, THEN 447MG/DL THE SECOND TIME. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET TWICE PRIOR TO HER ADMISSION. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR (B)(6). THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 310MG/DL AND SHE WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING ON THE INSULIN PUMP AND FOUND THAT THE BASAL, BOLUS, AND DAILY TOTALS WERE NOT ADDING CORRECTLY. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization