BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141771 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33542
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED FAILED SELF TEST DUE TO FAULTY REMOTE FREQUENCY BOARD. INSULIN PUMP PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY NOTED. NO HISTORY ANOMALY NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY CORNER, RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A RADIO FREQUENCY FAILED SELF-TEST ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE ALARM WAS RECEIVED ABOUT EVERY DAY SINCE SHE FIRST GOT THE PUMP. CUSTOMER STATED THAT THE ALARM DID NOT OCCUR DURING THE REWIND/PRIME SEQUENCE. CUSTOMER WAS ADVISED TO DISCONNECT AND REMOVE THE RESERVOIR FROM THE PUMP. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621089 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR