BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2990665 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91612
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE MOTOR SUPPORT DISK. UNABLE TO PERFORM OCCLUSION TEST OR VERIFY PRIME ALARMS DUE TO MOTOR ERROR ALARMS. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT LCD WINDOW CORNERS AND BATTERY TUBE THREADS. THE INSULIN PUMP WAS RECEIVED WITH 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE OF 263MG/DL. THE CALLER STATED THAT THE INSULIN PUMP STOPPED FUNCTIONING THE NIGHT BEFORE AND ALARMED DURING THE MANUAL PRIME PROCESS. TROUBLE SHOOTING WAS PERFORMED. THE DEVICE WAS STUCK ON THE PRIME LOOP, AND THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94300 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR