BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181317 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39634
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION,PRIME/A33 AND NO DELIVERY TESTS. NO EXCESSIVE "NO DELIVERY" ALARM NOTED. UNIT PASSED SELF TEST AND NO UNEXPECTED A64 ALARM NOTED. UNABLE TO DOWNLOAD HISTORY FILE USING CARELINK PRO DUE TO A47 ALARM FOUND IN ALARM HISTORY SCREEN. A47 ALARM DUE TO CORRUPTED HISTORY FILE. UNIT HAD CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A FAILED SELF TEST ALARM ON HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 167 MG/DL. HE ALSO REPORTED THAT THE ALARM OCCURS AT EXACTLY 10:01 EVERYDAY. HE STATED THE ALARM DID NOT OCCUR DURING THE REWIND/PRIME SEQUENCE. IT WAS ALSO FOUND A NO DELIVERY ALARM OCCURRED DURING TROUBLESHOOTING. TROUBLESHOOTING FOUND THE INSULIN WAS ABLE TO EXIT, BUT THE INSULIN PUMP ALARMED NO DELIVERY. IT WAS ALSO FOUND THE INSULIN PUMP ALARMED NO DELIVERY DURING A MANUAL PRIME. THE CUSTOMER WAS ADVISED TO REPLACE HIS INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661241 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR