BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103840 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-15800
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL THE OPERATING CURRENTS WERE WITHIN SPECIFICATION. OFF NO POWER ALARM DID FUNCTION PROPERLY. NO BLANK DISPLAY NOTED. NO DAMAGE FOUND ON THE LCD ISOLATION TAPE NOTED. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLANK DISPLAY ON THE INSULIN PUMP. CUSTOMER STATED THERE WERE SCRATCHES ON THE DISPLAY. CUSTOMER WAS ADVISED TO INSERT A NEW AAA ALKALINE BATTERY TO TEST WITH THE PUMP, BUT THE DISPLAY DID NOT RETURN. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER CALLED BACK AND SHE STATED THAT THE DISPLAY RETURNED AFTER SHE REPLACED THE BATTERY. CUSTOMER ALSO REPORTED THAT THERE WAS A CRACK ON THE INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOT THE PUMP FOR THE CRACK. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581836 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR