BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233952 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82796
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CHEST PAIN AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 149 MG/DL. THE CUSTOMER STATED THAT THE LAST INFUSION SET CHANGE WAS ON (B)(6) 2011. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 145 MG/DL AT BEDTIME, AND SHE WOKE UP WITH 386 MG/DL. THEN THE CUSTOMER PROGRAMMED AND DELIVERED 6.3 UNITS. HOWEVER, THE DAILY TOTAL FOR THE DAY OF THE EVENT WAS 15.9 UNITS. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP. THE PROGRAMMING AND ALARMS APPEARED TO BE CORRECT RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE TEST PASSED. THE CUSTOMER STATED THAT THE BUTTONS ARE HARD TO PRESS. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLANT. 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 Hospitalization PARADIGM: 9MM CATHETER| (B)(4) INFUSION SET: MMT-397| QUICK-SET: 23