BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183193 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39829
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    April 16, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACK ON THE BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACK ON THE RESERVOIR TUBE, AND BATTERY CAP SLOT IS CRACKED. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD PHYSICAL DAMAGE. CUSTOMER STATED THAT THE INSULIN PUMP HAD A CRACK WHERE THE RESERVOIR GOES. CUSTOMER'S BLOOD GLUCOSE WAS 176 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660862 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR