BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930700 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03730
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    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

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES OR FAILED BATTERY TEST ALARMS WERE NOTED. NO DAMAGE ON THE CONNECTOR TO LCD ISOLATION TAPE NOTED. THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS NOTED. HOWEVER, THE MOTOR HOME SWITCH RECEIVED CORRODED. UNABLE TO TEST MOTOR OUTSIDE THE DEVICE DUE TO MOTOR CORROSION. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND SEVERELY SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A MOTOR ERROR. HE STATED THAT HE TOOK OUT THE BATTERY AND THE PUMP WOULD NOT TURN BACK ON AFTER DOING SO. CUSTOMER STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED, BUMPED, OR EXPOSED TO MOISTURE. CUSTOMER INSERTED A NEW BATTERY INTO THE INSULIN PUMP BUT THE DISPLAY DID NOT RETURN. HE WAS ADVISED TO INSPECT THE CONTACTS ON THE BATTERY CAP AND STATED THAT THEY WERE NOT MISSING OR CORRODED. HE REPORTED THAT THE SPRING AND BATTERY COMPARTMENT WERE NEITHER DAMAGED NOR CORRODED. CUSTOMER ALSO MENTIONED THAT HE RECEIVED A FAILED BATTERY ALARM. CUSTOMER WAS ADVISED TO ENSURE THE BATTERY WAS SECURELY FASTENED AND TO CLEAN THE BATTERY CAP BUT THE DISPLAY STILL DID NOT RETURN. HE STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. HE WAS NOT ABLE TO REWIND THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS NOT KNOWN AT THE TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408622 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR