BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180912 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94879
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 MOTHER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE BOLUS DELIVERY, BUT THE ISSUE HAS BEEN RESOLVED. DURING THE CALL, THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AT THE BEGINNING OF (B)(6). THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 254MG/DL. IT WAS STATED THAT THE CUSTOMER HAD STOMACH PAIN, AND HE WAS FEELING LETHARGIC. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE MOTHER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280400 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization