BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141829 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33610
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 BY THE CUSTOMER'S WIFE THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS TWO NIGHTS IN A ROW. CUSTOMER WENT TO THE HOSPITAL FOR A URINARY TRACT INFECTION AND THERAPY. CUSTOMER IS NOW HOME AND THE HOSPITAL DID NOT WANT THE CUSTOMER ON THE PUMP DURING HIS STAY THERE. CUSTOMER'S WIFE STATED THAT THE ALARM WAS BEEPING DUE TO EMPTY RESERVOIR. CUSTOMER IS CURRENTLY OFF THE PUMP. CUSTOMER WAS TAKING NOVALOG AND COULD NOT REWIND THE PUMP. CUSTOMER'S WIFE STATED THAT THE MOST RECENT SET CHANGE WAS ON (B)(6) 2014. CUSTOMER WAS DISCONNECTED DURING THE REWIND/PRIME SEQUENCE. WHEN CUSTOMER GOT LOW BLOOD GLUCOSE LEVELS, THE NURSE ADVISED HIM TO TAKE THE PUMP ON THE SECOND AND GO ON LANTIS. CUSTOMER'S WIFE WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF ISSUES PERSIST. CUSTOMER'S WIFE STATED THAT THE PUMP WAS SUSPENDED AND WAS ASSISTED BY THE HELPLINE REPRESENTATIVE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621596 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization