BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 6030711 · Received October 14, 2016

    Report

    Report Number
    2032227-2016-30354
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 213 MG/DL. TROUBLESHOOTING WAS PERFORMED; THE CUSTOMER CHANGED THE INFUSION SET FIRST BUT THE NO DELIVERY ALARM WAS RESOLVED AND HE WAS ABLE TO PRIME AFTER CHANGING THE RESERVOIR. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682144 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8743784

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR