BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2853530 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91008
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 10MG/D. IT WAS STATED THAT THE CUSTOMER ALSO HAD RESPIRATORY PROBLEMS. THE DAUGHTER STATED THAT SHE PERCEIVED THE CUSTOMER'S LOW BLOOD GLUCOSE MAYBE WAS DUE TO AN OVERDOSE OF INSULIN. THE CUSTOMER WAS IN COMA WHEN SHE WAS FOUND BY THE DAUGHTER, AND THE RESERVOIR WAS EMPTY. IT WAS STATED THAT THE INFUSION SET WAS CHANGED THE SAME DAY OF THE ADMISSION. IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED DURING THE REWIND/PRIME PROCESS. TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER DID NOT HAVE THE INSULIN PUMP AT TIME OF CALL. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ADVISED THE CALLER THAT THE CUSTOMER SHOULD 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
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization