BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4160430 · Received September 20, 2014

    Report

    Report Number
    2032227-2014-25220
    Event Type
    Malfunction
    Date Received
    September 20, 2014
    Date of Event
    August 21, 2014
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF-TEST, UNEXPECTED ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. NO PRIME ALARM NOTED DURING TESTING. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE WINDOW, CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER AND STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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 THE INSULIN PUMP ALARMED DURING MANUAL PRIME. CUSTOMER DID NOT KNOW BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585737 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1