BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4201178 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42797
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED AND OR LOOSE DRIVE SUPPORT DISK, MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP, AND MISSING END CAP STICKER. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO PROTRUDED AND OR LOOSE DRIVE SUPPORT DISK. NO COMPROMISED FORCE SENSOR SYSTEM ALARMS NOTED. THE DEVICE ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED AND OR LOOSE DRIVE SUPPORT DISK.

    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. 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. 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 THAT THE CUSTOMER'S INSULIN PUMP WAS RECEIVING AN A33 ALARM. HER BLOOD GLUCOSE WAS 300MG/DL AT THE TIE OF REPORTING. SHE STATED THAT HER INSULIN PUMP WAS GETTING STUCK IN THE REWIND AND PRIME SEQUENCE. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682614 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1