BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1051244 · Received May 22, 2008

    Report

    Report Number
    3004209178-2008-00350
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT INSULIN LEAKED FROM THE TUBING AND RESERVOIR CONNECTION. THE CUSTOMER REPORTED A BLOOD GLUCOSE READING OF 201 MG/DL, WHICH SHE TREATED. ADVISED THE CUSTOMER TO MONITOR HER INSULIN PUMP AND BLOOD GLUCOSE LEVELS. ADVISED THE CUSTOMER TO CALL BACK AS NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1