BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032298 · Received March 22, 2011

    Report

    Report Number
    2032227-2011-00721
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 A HIGH BLOOD GLUCOSE READING OF 687 MG/DL. PRIOR TO BEING HOSPITALIZED, THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS DURING THE NIGHT, BUT DID NOT CHANGE THE INFUSION SET. THE CUSTOMER TREATED BY BOLUSING, AND THE INSULIN PUMP GAVE A GRINDING NOISE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS, BUT THE INSULIN PUMP CONTINUED MAKING A GRINDING SOUND. ADVISED 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-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization