BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4020384 · Received August 19, 2014

    Report

    Report Number
    2032227-2014-09646
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 19, 2014
    Report Date
    July 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO MOTOR ERROR OR EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST. THE TRANSMITTER COMMUNICATED PROPERLY WITH THE INSULIN PUMP AND NO CALIBRATION ERROR WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE NEAR THE RESERVOIR TUBE WINDOW.

    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

    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 AT 95 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD LED TO THE MOTOR ERROR ALARM. THE CUSTOMER WAS ADVISED THAT THEY CAN REDUCE THE LIKELIHOOD OF THESE OCCURRENCES BY ALLOWING THE BOLUS DELIVERY TO COMPLETE BEFORE ACCESSING THE SENSOR GLUCOSE GRAPH. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497189 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LCMS

    Patients

    Seq Age Sex Outcome Treatment
    1