BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090137 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81367
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOR HIGH BLOOD GLUCOSE OF 413MG/DL. THE CUSTOMER STATED THAT SHE FORGOT TO CHANGE THE SET UP FOR THE PAST FOUR DAYS. THE CUSTOMER DID NOT TREAT HER HIGH GLUCOSE WITH THE INSULIN PUMP OR WITH MANUAL INJECTIONS. THE CUSTOMER WAS NOT ABLE TO GET HER INFUSION SET INSERTED DUE TO BLEEDING AND PAIN AT THE SIGHT. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE TIME AND DATE. THE CUSTOMER STATED THAT THE LAST TIME SHE DID CHANGE THE INFUSION WAS THE DAY BEFORE HER ADMISSION. THE CUSTOMER TRIED TO DO THREE INSERTIONS WHILE BEING ON THE PHONE AND SHE WAS UNABLE TO COMPLETE DUE TO THE BLEEDING AND PAIN AT THE SITES. ADVISED THE CUSTOMER TO SEEK MEDICAL ADVICE AND REVERT TO BACK UP PLAN. THE CUSTOMER STATED THAT HER HUSBAND WILL TAKE HER TO THE EMERGENCY ROOM. 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization (B)(4) INFUSION QUICK-SET PARADIGM 23"M,| 9MM, MMT-397