BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-103A 10PK 3CC 13L STRL

    MDR report key: 1070388 · Received June 30, 2008

    Report

    Report Number
    2032227-2008-01090
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESERVOIR WAS LEAKING AT THE LUER CONNECTION. THE BLOOD GLUCOSE READING WAS 76MG/DL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-103A 10PK 3CC 13L STRL RESERVOIR FMF MEDTRONIC MINIMED MMT-103A

    Patients

    Seq Age Sex Outcome Treatment
    1