BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232468 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-82681
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 438MG/DL. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT, MANUAL PRIME, AND SELF TEST AND THE TESTS PASSED. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS AND HIS BLOOD GLUCOSE DROPPED TO 405MG/DL. A FOLLOW UP WAS COMPLETED AND FOUND THAT THE CUSTOMER HAD AN INTERMITTENT MOTOR ALARMS OVER (B)(6). ADVISED THAT THE CUSTOMER SHOULD DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. DURING THE CALL, IT WAS FOUND THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS OVER (B)(6). THE BLOOD GLUCOSE READING WAS 232MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR (B)(6). THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 209MG, AND HE HAS TREATED WITH THE INSULIN PUMP. NO FURTHER INFORMATION 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 10 YR Hospitalization (B)(4) INFUSION SET: MMT-381, SILHOUETTE 23"