BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1912667 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83268
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 532 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. IT WAS REPORTED THAT PRIOR TO THE EVENT THE CUSTOMER WAS HAVING PROBLEMS WITH THE CANNULAS ON HER INFUSION SETS BENDING. HOWEVER, THE CANNULA THAT WAS IN USE AT THE TIME OF THE EVENT WAS NOT BENT. THE TYPE OF INFUSION SET WAS NOT KNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization