BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3100711 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93234
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ELEVEN OPENED AND USED RESERVOIRS. PERFORMED PRE-FILL RESERVOIR TEST. FOUND ALL THE RESERVOIR'S NEEDLES NOT PARALLEL TO TRANSFER-GUARD BODY AXIS.INSPECTED THREE RANDOMLY SEALED RESERVOIRS. PERFORMED PRE-FILL RESERVOIRS TEST. FOUND ALL THREE OF THE RESERVOIR'S NEEDLES NOT PARALLEL TO TRANSFER-GUARD BODY AXIS.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR LEAKED INTO THE INSULIN PUMP. CUSTOMER'S DAUGHTER, STATED THAT THE TUBING CONNECTOR DOES NOT CLICK ONTO THE RESERVOIR AND DOES NOT FIT STRAIGHT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201614 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR