BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3121172 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93764
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 53MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT INSULIN PUMP ALARMED AND WAS STUCK ON THE PRIME LOOP. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED AND STICKING OUT. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222803 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR