BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4040712 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-98839
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO FAULTY FORCE SENSOR. NO ERROR ALARM NOTED. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT WHEN SETTING UP THE RESERVOIR AND PUT IN PRIME THE MOTOR WILL MOVE AND WHEN IT HITS THE BOTTOM OF SYRINGE IT WILL RESULT TO COMPROMISED FORCE SENSOR SYSTEM ERROR AND SHUT OFF. CUSTOMER'S BLOOD GLUCOSE WAS 243 MG/DL. TROUBLESHOOTING WAS DONE. ADVISED THE CUSTOMER THAT INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520986 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR