BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5840415 · Received August 2, 2016

    Report

    Report Number
    2032227-2016-14134
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME TEST AND MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS UNABLE TO PERFORM THE NO DELIVERY TEST DUE TO COMPROMISED FORCE SENSOR SYSTEM ALARM. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED DURING TESTING. 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 THEY RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM AND MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 264 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493779 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR