BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3830669 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84928
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    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. 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

    UNABLE TO PRIME INSULIN PUMP DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE DEVICE PASSED THE SELFTEST, OFF NO POWER, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY ALARM AND MOTOR TESTS. UNABLE TO COMPLETE THE PRIME TEST DUE TO THE PRIME ANOMALY. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS WITH NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS OBSERVED DURING ANALYSIS. A SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. CUSTOMER HAD INSERTED A NEW INFUSION SET ON FRIDAY NIGHT. IN THE MORNING CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS SO DECIDED TO CHANGE INFUSION SET IN THE AFTERNOON. BLOOD GLUCOSE LEVEL CONTINUED TO BE HIGH THE FOLLOWING THREE HOURS. AT ARRIVAL OF HOSPITALIZATION CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WAS 350-400 MG/DL. CUSTOMER WAS ON INSULIN DRIP AT HOSPITAL UNTIL HE COULD RECONNECT TO THE INSULIN PUMP. DURING TROUBLESHOOTING INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308563 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization