BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090433 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23116
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED; THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO CONFIRM E70 ALARM DUE TO ERASED HISTORY FILE. THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, PRIME/A33 AND DISPLACEMENT TESTS. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNERS AND RACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCING HIGH BLOOD GLUCSOE FOR SEVERAL WEEKS. THE INSULIN PUMP IS ALARMING MOTOR ERROR. THE BLOOD GLUCOSE READING IS 273 MG/DL. THE CUSTOMER HAS CONTACTED HER NURSE AND WAS ADVISED TO GET A REPLACEMENT INSULIN PUMP. CUSTOMER CHECKED THE BASAL SETTINGS; WHICH WERE GONE. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568793 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 68 YR