BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972322 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88826
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM WAS NOTED. THE INSULIN PUMP WAS MONITORED FOR 24 HOURS AND NO RESET ANOMALY WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM TESTS AND MOTOR TESTS. NO MOTOR ERROR ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY AND NO MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES, ELECTRONIC ASSEMBLY OR MOTOR. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A MOTOR ERROR ALARM ON THE INSULIN PUMP DURING REGULAR BASAL DELIVERY. CUSTOMER STATED THAT THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO MOISTURE AS HE HAD BEEN SITTING AT THE EDGE OF A POOL, BUT CANNOT REMEMBER IT GETTING WET. CUSTOMER STATED THAT HE HAD GONE THROUGH THE BODY SCAN MACHINE ABOUT FIVE TIMES BETWEEN (B)(6) WHILE WEARING THE INSULIN PUMP. CUSTOMER WAS ASSISTED IN CLEARING THE ALARM. HE STATED THAT HE WAS ABLE TO CLEAR THE ALARM. HE ALSO STATED THAT THE INSULIN PUMP HAD RESET ITSELF AND THAT HE HAD RECEIVED AN OFF NO POWER ALARM. THE BLOOD GLUCOSE READING WAS 173 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448144 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR