BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232415 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-82716
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS, BASAL, AND FIXED PRIME PROCESS. TROUBLESHOOTING WAS PERFORMED. THE REWIND AND MANUAL PRIME TEST PASSED. RAN SELF TEST AND PASSED. INSTRUCTED THE CALLER TO CHANGE THE INFUSION SET, RESERVOIR, AND CALL US BACK IF ISSUES CONTINUE. THE CUSTOMER'S HUSBAND CALLED BACK AND STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR MULTIPLE TIMES OVER THE PAST TWENTY FOUR HOURS. ADVISED THAT THE CUSTOMER SHOULD DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO BACK UP PLAN. DAYS LATER, THE HUSBAND CALLED BACK AGAIN AND STATED THAT THE CUSTOMER WAS HOSPITALIZED THE NIGHT BEFORE. 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 50 YR Hospitalization