BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5190259 · Received October 30, 2015

    Report

    Report Number
    2032227-2015-61445
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 ALARMED MOTOR ERROR DURING THE OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR HOWEVER, THE MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER AND MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE CALLED IN TO REPORT A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CALLER COMPLETED TROUBLESHOOTING AND WAS ABLE TO REWIND AND FILL THE TUBING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS INFORMED THAT THE DEVICE WOULD BE REPLACED, AND WAS INFORMED TO RETURN THE MALFUNCTIONING DEVICE BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722434 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 51 YR