BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    MDR report key: 1912660 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83261
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE ALSO MFR REPORT NUMBER 2032227-2010-83241.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND VOMITING. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 584 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. NO INFUSION SITE OR SET PROBLEMS WERE NOTED. THE CUSTOMER USES QUICK-SET INFUSION SETS. AT THE TIME OF THE REPORT, THE INSULIN PUMP ALARMED NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization