BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103798 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26570
    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
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO VERIFY THE ERROR ALARM, BATTERY OUT LIMIT ALARM, AND OFF NO POWER ALARM. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE BLANK DISPLAY. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD ALARMED FOR ERRORS AND HAD SUDDENLY SHUT DOWN. THE BLOOD GLUCOSE READING WAS 96 MG/DL. SHE STATED THAT THE ALARM OCCURRED AFTER A BATTERY CHANGE. SHE STATED THAT THE BASAL RATES WERE RETAINED. SHE STATED THAT THE BATTERIES HAD BEEN OUTSIDE OF THE INSULIN PUMP FOR AN EXTENDED PERIOD OF TIME. CUSTOMER HAD NOT RECEIVED ANY BATTERY OUT LIMIT ALARMS AND THAT THE ERROR ALARMS WERE RECURRING DESPITE TROUBLESHOOTING SEVERAL TIMES. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO MOISTURE OR DROPPED OR BUMPED. SHE STATED THAT THE BATTERY CAP CONTACTS WERE NOT MISSING OR DAMAGED AND THAT THE BATTERY COMPARTMENT AND SPRING WERE NOT DAMAGED OR CORRODED. SHE WAS ADVISED TO INSERT A FRESH BATTERY AND STATED THAT THE DISPLAY DID RETURN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583844 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR