BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982266 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90284
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, MISSING END CAP STICKER, CRACKED RESERVOIR WINDOW, CRACKED RESERVOIR TUBE AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS. THE DEVICE WAS MONITORED AND NO UNEXPECTED BATTERY OUT LIMIT ALARMS NOTED. ALL OPERATING CURRENTS TEST WERE WITHIN SPECIFICATION RANGE. HOWEVER, THE INSULIN PUMP ALARMED AN ERROR DURING THE PRIME TEST DUE TO MOISTURE DAMAGE NOTED IN THE FORCE SENSOR.

    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

    CUSTOMER'S HUSBAND CALLED STATING HE WAS CHANGING HIS WIFE'S RESERVOIR AND THE INSULIN PUMP STARTING SHOOTING OUT INSULIN AND THEN IT ALARMED. INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. THE DEVICE ALSO ALARMED BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE WAS 97 MG/DL. SHE REMOVED THE BATTERY BUT THE ALARM DID NOT CLEAR. THE DEVICE WAS NOT DROPPED. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE BATTERIES WERE OUT OF THE DEVICE LONGER THAN ALLOWED BY THE DEVICE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456998 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 50 YR