BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142026 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33640
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. NO A35 ALARM OR CHECK SETTINGS ALARM NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED; THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO PERFORM THE EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO MOTOR ERROR ALARMS. THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION AND PRIME/A33 TESTS. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP AND 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO PRIME WHEN SHE RECEIVED A MOTOR ERROR ON THE INSULIN PUMP. CUSTOMER REFILLED HER RESERVOIR AND PUT THE RESERVOIR IN THE PUMP. CUSTOMER STATED THAT SHE FELT LIKE IT DIDN'T CLICK WHEN THE RESERVOIR WAS PLACED IN THE PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 149 MG/DL. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER STATED THAT SHE WENT THROUGH A METAL DETECTOR WHEN SHE FLEW LAST WEEK. A MOTION SENSOR TEST FAILURE ALARM AND A NO DELIVERY ALARM WERE FOUND IN THE ALARM HISTORY. CUSTOMER STATED THAT SHE WAS ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO RETURN THE PUMP WITH THE BATTERY AND TO ZERO OUT THE BASAL RATES. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621681 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR