BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171131 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01707
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST (B)(6). AT THE HOSPITAL, THE MOTHER WAS TOLD THAT THE CUSTOMER MAY HAVE HAD A VIRUS, BUT THE MOTHER DID NOT HAVE MUCH CONFIDENCE IN THE DIAGNOSIS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE MOTHER DIDN'T HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. 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-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization MMT-399, LOT 2209668| (B)(4) QUICK-SET PARADIGM INSULIN INFUSION SET: