BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1081759 · Received July 18, 2008

    Report

    Report Number
    2032227-2008-01253
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS REPORTED THAT THE RESERVOIR LEAKED. THE BLOOD GLUCOSE READING WAS NOT REPORTED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10 PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC MINIMED MMT-326A WK0507605

    Patients

    Seq Age Sex Outcome Treatment
    1