BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110577 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27425
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM WAS NOTED. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, NO DELIVERY AND MOTOR TESTS. NO MOTOR ERROR ALARM OR MOTOR ANOMALY WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED THAT HIS SON'S BLOOD GLUCOSE WAS OVER 400 MG/DL. THE FATHER STATED THAT HE HAD ALREADY CHANGED THE INFUSION SET AND THE INSULIN PUMP WAS NOT DELIVERING INSULIN TO HIS SON. THE SON'S BLOOD GLUCOSE WAS LOWERED WITH A MANUAL INJECTION. THE FATHER STATED THE INSULIN PUMP'S DRIVE SUPPORT CAP APPEARED TO BE NORMAL. IT WAS ALSO FOUND THAT THERE WAS NO AIR IN THE INSULIN PUMP'S TUBING. THE FATHER STATED THAT THERE WAS A PROBLEM WITH THE MOTOR DURING A REWIND OF THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THE INSULIN PUMP NEEDED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589959 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR