BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5853437 · Received August 8, 2016

    Report

    Report Number
    2032227-2016-15468
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS NOTED THAT THE INSULIN PUMP UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THERE WAS NO A33 ALARM NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER. 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

    IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THE INSULIN SQUIRTED OUT DURING MANUAL PRIME AND THEY WERE UNABLE TO PRIME. DURING TROUBLE SHOOTING THE SHE STATED THERE WAS NO GAB BETWEEN THE PISTON AND RESERVOIR. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505755 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR