BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4180719 · Received August 2, 2014

    Report

    Report Number
    3004209178-2014-89126
    Event Type
    Malfunction
    Date Received
    August 2, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, BASIC OCCLUSION TEST AND PRIME TEST. INSULIN PUMP RECEIVED WITH STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. INSULIN PUMP WAS UNABLE TO TEST EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. UNABLE TO VERIFY EXCESSIVE NO DELIVERY ALARM DUE TO MOTOR ERROR ALARM. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED FOR MOTOR ERROR AND NO DELIVERY. BLOOD GLUCOSE READING AT THE TIME WAS 147 MG/DL. CUSTOMER MENTIONED THAT THE PISTON WILL NOT PUSH RESERVOIR AND IT IS STUCK IN THE CHAMBER. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452823 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR