BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5081443 · Received September 16, 2015

    Report

    Report Number
    2032227-2015-44261
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED; THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO VERIFY E70 ALARM IN THE ALARM HISTORY DUE TO HISTORY FILE OVER WRITTEN. THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, PRIME/A33 AND DISPLACEMENT TESTS. THE INSULIN PUMP HAS CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT AFTER CHANGING THE BATTERY SHE RECEIVED A MOTOR ERROR ALARM AND A MOTOR POSITION ENCODER ERROR. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED, AND WAS INFORMED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612200 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR