BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1161649 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01593
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 STATED THAT HE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER STATED THAT PRIOR TO THE EVENT THE INSULIN PUMP HAD ALARMED. NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS ABLE TO PRIME WITHOUT A RESERVOIR IN PLACE. WHEN THE CUSTOMER ATTEMPTED TO PRIME THE RESERVOIR BY HAND, HE STATED THAT THE RESERVOIR WAS VERY STIFF, AND IT TOOK A GREAT DEAL OF PRESSURE TO PUSH INSULIN FROM THE RESERVOIR INTO THE TUBING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC MINIMED MMT-332A 2207133

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization