BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2200790 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82373
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR THREE DAYS DUE TO A COMA. IT WAS STATED THAT THE CUSTOMER'S GLUCOSE READING WAS 500MG/DL AT TIME OF THE EVENT. IT WAS STATED THAT THE CUSTOMER BLOOD GLUCOSE WAS 440MG/DL WHEN HE WAS RELEASED AND WAS TREATED WITH MANUAL INJECTIONS. THE WIFE CALLED BACK AND STATED THAT THE CUSTOMER STILL IS EXPERIENCING HIGH AND LOW BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER WOKE UP WITH A GLUCOSE READING OF 57MG/DL, BUT THE DAY BEFORE HIS GLUCOSE LEVEL WAS 119MG/DL FOR MOST OF THE DAY. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND THAT THE CUSTOMER HAD CHANGED THE FIXED PRIME TO 2.8 UNITS. ADVISED WIFE CHANGING TO 0.5 UNITS. RAN TO FIXED PRIME TEST AND INSULIN EXITED. THE WIFE BELIEVES THAT THE CUSTOMER MAY HAVE PROGRAMMED BOLUSES THAT SHE IS NOT AWARE OF IT. ALSO FOUND THAT THE CUSTOMER POSSIBLE REUSES THE SUPPLIES AND DOES NOT ALTERNATE THE SITES. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization PARADIGM 9MM CATHETER| UNOMEDICAL INFUSION SET: (B)(4), QUICK-SET: 23