BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201191 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42807
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST, DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. MOTOR PASSED MOTOR TEST. UNABLE TO VERIFY PRIME ALARM, DUE TO MOTOR ERROR ALARM. INSULIN PUMP RECEIVED WITH PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN A33 ALARM ON HER INSULIN PUMP. HER BLOOD GLUCOSE WAS 200MG/DL AT THE TIME OF REPORTING. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP. THE PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681637 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR