BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4211657 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44912
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO LOOSE AND OR PROTRUDED DRIVE SUPPORT DISK. COMPROMISED FORCE SENSOR SYSTEM ALARMS WERE NOT CONFIRMED DUE TO MOTOR ERROR ALARMS. MISSING END CAP STICKER NOTED. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR ALARM DURING THE MANUAL PRIME. CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED IN THE PAST AND THE DRIVE SUPPORT CAP WAS NOTED TO BE STICKING OUT. CUSTOMER STATED THAT THEY PUSHED THE DRIVE SUPPORT CAP BACK IN. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 208 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692130 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR