BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1233932 · Received November 14, 2008

    Report

    Report Number
    2032227-2008-01957
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 492 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAS BEEN EXPERIENCING BLEEDING AT HER INFUSION SITES. THE PRIME AND HIGH PRESSURE TESTS PASSED. THE CUSTOMER WAS SENT SOME ALTERNATE INFUSION SETS TO TRY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAB PRDGM INS BL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization