BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193031 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41777
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR GOLD. NO A33 ALARM NOTED DURING OUR TESTING. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT HE TRIED FILLING THE RESERVOIR ABOUT 3 DAYS AGO. CUSTOMER HAD AN ERROR CODE. CUSTOMER HAS TRIED TO FILL THE RESERVOIR 4 TIMES, BUT HE KEEPS GETTING THE ALARMS. CUSTOMER STATED THAT THE INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP. CUSTOMER ALSO MENTIONED THAT THE DOME LABEL STICKER IS MISSING AND THE BELT CLIP HAS BEEN BROKEN. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672097 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 25 YR