BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5192627 · Received October 30, 2015

    Report

    Report Number
    2032227-2015-61747
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY AND MOTOR POSITION ENCODER ERROR ALARM WAS CONFIRMED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. DEVICE PASSED THE REWIND BASIC OCCLUSION TEST, PRIME AND DISPLACEMENT TEST. DEVICE WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNERS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND. THE DRIVE SUPPORT CAP IS RECESSED. THE DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. THE CUSTOMER STATED SHE HAD 3 MOTOR ERROR ALARMS WITHIN THE LAST TWO HOURS AND A MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER WAS ABLE TO REWIND BUT ONCE SHE GOES TO FILL CANNULA IT ALARMED AGAIN. BLOOD GLUCOSE VALUE WAS 200 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE INSULIN PUMP WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721110 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR