BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103491 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26400
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO UNEXPECTED LOW BATTERY ALARM NOTED. NO WEAK BATTERY ALARM, NO BLANK DISPLAY AND NO BAD BATTERY ALARM FOUND. THE LOW RESERVOIR ALARM DID FUNCTION PROPERLY DURING TESTING. ALL THE BUTTONS FUNCTIONED CORRECTLY AND NO DAMAGE ON THE KEYPAD ASSEMBLY NOTED. NO MOISTURE DAMAGE FOUND INSIDE THE DEVICE. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    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 THE DISPLAY ON HIS INSULIN PUMP WAS BLANK, AFTER EXPOSURE TO PERSPIRATION. THERE WAS NO LOW BATTERY ALERT, PRIOR TO THE SCREEN GOING BLANK. THE CUSTOMER'S BLOOD GLUCOSE WAS 147 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER STATED THAT THE SPRING IN THE BATTERY COMPARTMENT WAS CORRODED. THE CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY AND THE DISPLAY RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584149 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR