BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173734 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38356
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME TEST AND DISPLACEMENT TEST. HOWEVER, THE DEVICE WAS RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. MOTOR POSITION ENCODER ERROR ALARM WAS NOT VERIFIED DUE TO ERASED HISTORY FILE CAUSED BY SEVERAL DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP ALARMS IN THE HISTORY FILE. ALARMS WERE DUE TO A CORRUPTED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE DEVICE HAD MINOR SCRATCHES TO LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THEIR INSULIN PUMP WHILE SHE WAS TRYING TO BOLUS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655389 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1