BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6018309 · Received October 11, 2016

    Report

    Report Number
    2032227-2016-27180
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME/ COMPROMISED FORCE SENSOR ALARM TEST DUE TO CRACKED END CAP. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND MISSING END CAP STICKER NOTED DURING VISUAL INSPECTION. 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP HAD A PRIME/FILL ANOMALY. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 240 MG/DL. THE CUSTOMER STATES THE INSULIN SQUIRTED OUT, DURING MANUAL PRIME. THE CUSTOMER WAS NOT WEARING THE PUMP WHILE PRIMING. TROUBLESHOOTING WAS PERFORMED AND DETERMINE THE TOP OF THE RESERVOIR WAS NOT WET, AND NO GAB BETWEEN THE PISTON AND RESERVOIR. THE RESERVOIR VOLUME DID NOT MATCH WHAT WAS ON THE SCREEN. ALSO THE INSULIN CONTINUES TO DRIP AFTER LETTING GO OF THE ACT BUTTON. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE. THE DEVICE WILL BE RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670357 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR