BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4233111 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48684
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NO DELIVERY ALARM WAS RECEIVED ON THE INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE WAS 493 MG/DL AND HE WAS TREATED WITH MANUAL INJECTION. THE ALARM WAS REPORTEDLY RESOLVED BY A COMPLETE SET CHANGE, POSSIBLY INDICATING A CONNECTION ISSUE OR OCCLUSION INVOLVING THE INSERTION SITE, SET, AND/OR RESERVOIR. THE NO DELIVERY ALARM DID NOT OCCUR DURING A MANUAL PRIME. IT WAS NOT POSSIBLE TO TROUBLESHOOT AT THE TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714464 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG07GT3

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR