BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2202526 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82455
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR KETONES AND HIGH BLOOD GLUCOSE OF OVER 600MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST TWENTY FOUR HRS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 132MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PASSED THE TESTS. SUGGESTED ALTERNATE INFUSION SETS AND SITES. IT WAS STATED THAT THE CUSTOMER WENT THROUGH HALF A BOX OF MIO INFUSION SETS AND SHE WANTS TO HAVE THEM REPLACED. IT WAS STATED THAT THE CUSTOMER ALSO HAD PROBLEMS WITH THE BLOOD GLUCOSE METER BECAUSE THE READING WAS HIGHER THAN WHAT WAS TAKEN AT 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-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization UNOMEDICAL INFUSION SET: MMT-921| MIO SET 18"| 6MM PINK