BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2033871 · Received March 17, 2011

    Report

    Report Number
    2032227-2011-00686
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 BEING HOSPITALIZED WITH SYMPTOMS OF LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE READING AT BEDTIME WAS 100 MG/DL. WHEN THE PARAMEDICS ARRIVED TO HER HOME, THE CUSTOMER HAD SYMPTOMS OF LOW BLOOD GLUCOSE LEVELS, BUT HER READING WAS 178 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. REVIEWED THE BOLUS HISTORY, AND THERE CUSTOMER STATED THAT THERE WERE TWO BOLUSES IN THE HISTORY THAT SHE DID NOT PROGRAM. THE RESERVOIR VOLUME WAS CORRECT. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization