BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2231576 · Received July 22, 2011

    Report

    Report Number
    2032227-2011-01803
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE HAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST FOUR DAYS. THE CUSTOMER HAS NOT BEEN HOSPITALIZED, BUT STATED SHE WOULD BE SEEING HER DOCTOR TOMORROW. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER STATED THAT SHE SMELLED INSULIN, AND BELIEVED THAT HER PREVIOUS RESERVOIR WAS LEAKING AS WELL. 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-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR (B)(4) QUICK-SET PARADIGM INSULIN INFUSION SET:| MMT-397