BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2874276 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-91389
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INFUSION SET WAS CHANGED, AND ONE HOUR LATER SHE WAS FEELING SICK, VOMITING, AND HAD CHEST PAIN. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 555MG/DL BY THE TIME THE PARAMEDICS ARRIVED. ONCE SHE GOT TO THE HOSPITAL THEY DID A VENOUS CHECK AND HER BLOOD GLUCOSE READING WAS 505MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. THE CUSTOMER MENTIONED THAT SHE DID NOT GET INSULIN BECAUSE THE CANNULA WAS BENT, AND THE INSULIN PUMP DID NOT ALARM. ADVISED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO COMPLETE TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization