BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972389 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05175
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND MONITORED. ALL THE BOLUSES WERE DELIVERED COMPLETELY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE BOLUS HISTORY SCREEN. NO BOLUS ANOMALY NOTED. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP. 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

    THE CUSTOMER'S ASSISTANT CALLED IN TO REPORT THAT SHE WASN'T SURE IF THE CUSTOMER'S BOLUS DELIVERED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT IS UNKNOWN. THE CUSTOMER FEELS THAT THE BUTTONS ARE WORKING PROPERLY AND THE PUMP PASSED THE SELF TEST. HOWEVER, THE CUSTOMER'S DOCTOR RECOMMENDED THE CUSTOMER GET THE PUMP REPLACED. WE ASKED THE CUSTOMER IN VERBALLY AND WRITTEN FORM TO RETURN THE BROKEN PUMP FOR ANALYSIS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446660 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR