BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202406 · Received August 4, 2011

    Report

    Report Number
    2032227-2011-01951
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY STATED THAT HE FELT THE INSULIN PUMP WAS NOT DELIVERING INSULIN WHEN THE RESERVOIR REACHES A CERTAIN LEVEL. THE CUSTOMER THEN REPORTED THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 600 MG/DL. THE CUSTOMER STATED THAT HE HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST COUPLE OF WEEKS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER LATER CALLED TO REPORT THAT HE HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS EVER SINCE HE DROPPED THE INSULIN PUMP. THE CUSTOMER STATED THAT HE WOULD FEEL MORE COMFORTABLE HAVING THE INSULIN PUMP 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Congenital Anomaly UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| (B)(4), LOT 9201823