BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4820200 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62748
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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 PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK ON A MOTOR ERROR ALARM LOOP THAT OCCURRED DURING A 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. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A SHIFTED END CAP STICKER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP ALARMED MOTOR ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 167 MG/DL AT THE TIME OF THE CALL. CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE PUMP. CUSTOMER STATES THEY ARE UNABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361550 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR