BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 6030899 · Received October 14, 2016

    Report

    Report Number
    2032227-2016-30331
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS NOT REQUIRED. THE RESERVOIR IS EXPIRED. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 270 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY WERE UNABLE TO PUSH INSULIN THROUGH THE RESERVOIR DURING PLUNGER PUSH. THE CUSTOMER WAS ADVISED TO ASSEMBLE NEW RESERVOIR AND INFUSION SET. THE CUSTOMER PERFORMED FIXED PRIME AND THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682790 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A WA1504130

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR