BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2252932 · Received September 12, 2011

    Report

    Report Number
    3004209178-2011-82897
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 ADMITTED AT THE INTENSIVE CARE UNIT DUE TO DIABETES KETOACIDOSIS AND INFECTION. THE CUSTOMER STATED THAT SHE HAS BEEN IN THE HOSP FOR TWO WEEKS, AND LAST WEEK HER GLUCOSE READING WAS OVER 500 MG/DL. THE CUSTOMER STATED THAT THE DOCTOR BELIEVES THAT MOST LIKELY THE REASON WAS THE SITE, AND SHE HAS SCAR TISSUE. THE CUSTOMER STATED THAT SHE DID NOT RECEIVE A NO DELIVERY ALARM. ADVISED THE CUSTOMER TO CALL BACK WHEN SHE CAN TROUBLESHOOT THE INSULIN PUMP. 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-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization