BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183555 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40110
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. NO MOTOR ERROR ALARM NOTED. UNABLE TO PERFORM EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO PRIME FILL ANOMALY. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH BATTERY TUBE THREADS CRACKED, CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNER.

    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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS. CUSTOMER'S BLOOD GLUCOSE READING WAS 324 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. IT WAS REPORTED THAT CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663957 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 63 YR