BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6003562 · Received October 6, 2016

    Report

    Report Number
    2032227-2016-26537
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    March 1, 2014
    Report Date
    March 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS NOTED THAT THE PUMP PASSED REWIND, BASIC OCCLUSION, PRIME/COMPROMISED FORCE SENSOR SYSTEM AND DISPLACEMENT TESTS. THE PUMP WAS STUCK IN A MOTOR ERROR ALARM LOOP DURING BOLUS/BASAL DELIVERY AND MOTOR POSITION ENCODER ERROR ALARM NOTED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING THE TESTING. THE DRIVE SUPPORT DISK HAD NO ANOMALY. THE PUMP HAD CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND SCRATCHED DISPLAY WINDOW. THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 78 MG/DL. THE CUSTOMER STATED THAT THE PUMP WAS DROPPED EARLIER AND IT SEEMED TO BE FINE. THE DRIVE SUPPORT DISK WAS NORMAL AND THE PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655377 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR