BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2182461 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-82176
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 600MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE RECEIVES SEVERAL NO DELIVERY ALARMS. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST FEW DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 178MG/DL, AND WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND NO INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE TEST FAILED. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization QUICK-SET PARADIGM 43"| UNOMEDICAL INFUSION SET: (B)(4)| 9MM CATHETER