BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972323 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88693
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY GOLD FORCE SENSOR RESISTOR. THE NO DELIVERY TEST COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND AND BASIC OCCLUSION TESTS. NO MOTOR ERROR ALARMS WERE NOTED AND THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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'S HUSBAND REPORTED A MOTOR ERROR ALARM AND NO DELIVERY ALARMS. THE BLOOD GLUCOSE READING IS 326 MG/DL. CUSTOMER HAS TREATED WITH MANUAL INJECTION. CUSTOMER RECEIVED THE MOTOR ERROR ALARM AFTER REPLACING THE BATTERY. CUSTOMER TRIED TO PRIME THE INSULIN PUMP, BUT KEPT RECEIVING NO DELIVERY ALARMS. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448551 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 59 YR