BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2200756 · Received July 27, 2011

    Report

    Report Number
    3004209178-2011-82297
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 900-1000MG/DL. IT WAS STATED THAT THE CUSTOMER MENTIONED HAVING HIGH BLOOD GLUCOSE DURING A DIALYSIS PROCEDURE. THE CUSTOMER REPORTED EXPERIENCING HIGH GLUCOSE FOR THE PAST FOUR DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 200MG/DL, AND HE WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THE TIME WAS INCORRECT. ASSISTED THE CUSTOMER IN FIXING THE TIME. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization QUICK-SET 23| PARADIGM 9MM CATHETER| UNOMEDICAL INFUSION SET: MMT-397