BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190292 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01785
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 600 MG/DL. THE CUSTOMER STATED THAT SHE IS PREGNANT, AND HAS BEEN UNDER A LOT OF STRESS. THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. DURING THE CALL, THE CUSTOMER RAN A MANUAL PRIME. THE INSULIN PUMP SQUIRTED OUT THE INSULIN, AND ALARMED MOTOR ERROR DURING THE PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, BUT CONTINUED TO ALARM MOTOR ERROR. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization