BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL - TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143382 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30171
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARMS WERE NOTED. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND MOTOR TESTS. NO EXCESSIVE NO DELIVERY ALARM OR MOTOR ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    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.

    Description of Event or Problem · 1

    CUSTOMER INQUIRED ABOUT THE SAFETY NOTIFICATION ON THE SCROLL WRAP FEATURE ON HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 38 MG/DL. THE CUSTOMER ALSO REPORTED HE HAD A NO DELIVERY ALARM THE PREVIOUS WEEK. CUSTOMER STATED HE HAD TREATED HIS LOW BLOOD GLUCOSE WITH DINNER. THE CUSTOMER'S BLOOD GLUCOSE HAD INCREASED TO 99 MG/DL. HE STATED THERE WAS NO DAMAGE TO HIS INSULIN PUMP. HE ALSO STATED HIS BASAL RATES WERE CORRECT. THE CUSTOMER'S INSULIN PUMP ALSO PASSED THE DISPLACEMENT TEST. CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603631 PARADIGM REAL - TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR