BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML MMT-326A

    MDR report key: 7608753 · Received June 18, 2018

    Report

    Report Number
    3004209178-2018-82366
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 18, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    00643169771437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CANNOT PERFORMED MANUAL TEST PER (B)(4) APPENDIX G TO RESERVOIR DUE TO THE RESERVOIR DISLODGE (PLUNGER TO STOPPER-PLUNGER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN PUMP HAD TROUBLE WITH MINIMED RESERVOIRS AND LOSES ALL THE INSULIN. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 236 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451492 RESERVOIR 1.8ML MMT-326A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG1KHP9 00643169771437

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR