BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1845048 · Received September 13, 2010

    Report

    Report Number
    3004209178-2010-82802
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT AIR BUBBLES IN THE RESERVOIR AND MOISTURE IN THE RESERVOIR COMPARTMENT WERE OBSERVED. THE CUSTOMER ALSO STATED THAT SHE SMELLS INSULIN INSIDE THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7635759

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR