BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142277 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33405
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    INSULIN PUMP PASSED BASIC OCCLUSION AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS NOTED. HOWEVER, UNABLE TO PRIME DURING PRIME AND TEST DUE TO SLIGHTLY LOOSE DRIVE SUPPORT DISK. INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4).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.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 WAS REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. ALARM WAS EXPLAINED TO THE CUSTOMER AND CLEARED. THE DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. CUSTOMER WAS ADVISED TO DO DELIVER FIVE UNITS VIA FILL CANNULA AND NO ALARM OCCURRED. CUSTOMER DID A COMPLETE SET CHANGE. THE INFUSION TUBE WAS FILLED MANUALLY. ALARM HAD OCCURRED TWICE IN THE LAST TWO MONTHS. CUSTOMER DID NOT KNOW BLOOD GLUCOSE VALUE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622054 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1