BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240661 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49772
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED RESTARTS, TIME AND OR DATE RESETS, BLANK DISPLAYS, EXTERNAL RAM CRC ERROR ALARMS, LOW BATTERY ALERTS, RESERVOIR VOLUME ICON ANOMALIES AND PRIME AND OR FILL ANOMALIES NOTED DURING TESTING. THE INSULIN PUMP PASSED DISPLACEMENT TEST, OFF NO POWER TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, AND OCCLUSION TEST. THE OPERATING CURRENTS WERE WITHIN SPECIFICATIONS. CONSTANT UNEXPECTED RESTART ALARMS DURING BATTERY CHANGE DUE TO FAULTY CONNECTOR ON INTERFACE BOARD. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD RECEIVED MULTIPLE ALARMS ON THE INSULIN PUMP. HER BLOOD GLUCOSE WAS 202 MG/DL. THE CUSTOMER STATED THAT SHE WAS HAVING TO INPUT THE TIME AND DATE IN THE INSULIN PUMP EVERY TIME SHE WOULD CHANGE THE BATTERY. SHE FURTHER STATED THAT SHE NEVER SAW ONE OF THE ALARMS THAT WAS FOUND IN THE HISTORY OF THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, BUT UPON STATING THAT SHE DID NOT WISH TO DO SO, THE CUSTOMER WAS ADVISED TO MONITOR HERSELF. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724057 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR