BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211973 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95483
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, SELF TEST AND ERROR TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST AND ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO ALARM OR REWIND ANOMALY NOTED. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST OR TEST THE INSULIN INDICATOR ICON DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW AND A 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE OF 14MG/DL. THE CUSTOMER STATED THAT HER INSULIN PUMP DELIVERED 30.0 UNITS OF INSULIN INTO HER BODY. TROUBLESHOOTING WAS PERFORMED, AND SHE WAS UNSURE IF THE DRIVE SUPPORT CAP WAS PROTRUDED OR LOOSE. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED WHILE ATTEMPTING TO REWIND AND PRIME. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310266 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization