BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 7497756 · Received May 9, 2018

    Report

    Report Number
    3004209178-2018-70269
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 15, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    00643169786554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AN AIR BUBBLE ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 226 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTS THAT THE APPROXIMATE SIZE OF AIR BUBBLES WAS ANYWHERE FROM A PIN HEAD TO A LITTLE BIT LARGER. CUSTOMER REPORT THAT AIR BUBBLE DOWN BY O-RING AND BETWEEN 0 AND 1 ON RESERVOIR AND JUST BEFORE TOP OF RESERVOIR. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341255 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG29SP6 00643169786554

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR