BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3023012 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92126
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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 ALARM DURING BASIC OCCLUSION TEST DUE TO LOOSE PROTRUDED DRIVE SUPPORT DISK. UNIT WAS RECEIVED WITH EXCESSIVE ADHESIVE AROUND THE END CAP. CRACKED END CAP, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND WINDOW NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END CAP FELL OFF, AND THE INSULIN PUMP ALARMED. THE BLOOD GLUCOSE READING WAS 7.1MMOL/L. IT WAS STATED THAT THE DEVICE WAS BUMPED AND CRACKED. IT WAS ALSO STATED THAT CUSTOMER HAD ISSUES WITH PRIME/REWIND, AND THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126665 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1