BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6079565 · Received November 4, 2016

    Report

    Report Number
    2032227-2016-35465
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    November 16, 2013
    Report Date
    November 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO EXCESSIVE NO DELIVERY ALARMS NOTED. HOWEVER, AN UNEXPECTED MOTOR NOISE WAS NOTED DURING THE REWIND; PROBLEM ISOLATED TO MOTOR. IT ALSO HAD A CRACKED CASE AT LCD WINDOW CORNER, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP AND SCRATCHED LCD WINDOW. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON (B)(6) 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 THE INSULIN PUMP MAKES A GRINDING NOISE DURING REWIND AND ALARMED NO DELIVERY DURING PRIME. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 300 MG/DL; TREATED WITH MANUAL INJECTIONS. DURING THE CALL, THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND WAS ABLE TO PRIME. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAS A CRACKED RESERVOIR COMPARTMENT AND SCREEN. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731159 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR UNOMEDICAL INSULIN INFUSION SET