BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4130616 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-96173
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING THE OCCLUSION TEST AND ALARMED PRIME DURING PRIME TEST AT 4LBS DUE TO FAULTY FORCE SENSOR. MOTOR PASSED MOTOR TEST. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP AND MINOR SCRATCHES ON 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

    IT WAS REPORTED THAT THE CUSTOMER WAS CHANGING RESERVOIR AND GOT COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER BLOOD GLUCOSE WAS 210 MG/DL. TROUBLESHOOTING WAS DONE. DURING TROUBLESHOOTING CUSTOMER HAD MOTOR ERROR ALARM DURING BOLUS DELIVERY. ADVISED CUSTOMER THAT INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609384 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR