BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4170406 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37928
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-37929.

    Additional Manufacturer Narrative · 1

    EVALUATED ONE OPENED/USED RESERVOIR AND PERFORMED VISUAL INSPECTION, FAILED PER SPECIFICATION DUE TO SNAP-CAP DETACHED FROM RESERVOIR'S BARREL. FOUND SNAP-CAP ATTACHED TO TRANSFER GUARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PROBLEMS WITH HER INFUSION SET AND RESERVOIRS. THE CUSTOMER STATED SHE WAS HAVING BLOOD GLUCOSE OVER 500 MG/DL DESPITE HAVING INSULIN DELIVERED TO HER BODY. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE INSULIN PUMP. SHE ALSO REPORTED THAT SHE HAD A RESERVOIR THAT DID NOT ALLOW HER TO PULL THE TRANSFER GUARD ALL THE WAY. THE CUSTOMER ALSO STATED HER CANNULA WAS NOT BENT AND THERE WAS INSULIN POURING OUT OF THE SITE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650872 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG050RU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR