BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182593 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39695
    Event Type
    Malfunction
    Date Received
    October 17, 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
    OR
    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. THIS MDR RELATED TO THE (B)(4)MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE OCCLUSION TEST, EXCESSIVE NO DELIVERY ALARM TEST, AND PRIME TEST COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARMS. THE INSULIN PUMP HAD OPERATING CURRENTS WITHIN SPECIFICATION AND PASSED THE SELF TEST, RESET ERROR TEST AND DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, A BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TNE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND HAD LOOSE DRIVE SUPPORT CAP. CUSTOMER STATED WAS TRYING TO PRIME AND GOT COMPROMISED FORCE SENSOR FORCE SYSTEM ALARM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 124 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. CUSTOMER MENTIONED THAT SHE WENT OFF THE INSULIN PUMP FOR A WHILE DUE TO HIGH BLOOD GLUCOSE AND WENT BACK ON THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT RECOGNIZING THAT IT WAS GOING THROUGH THE TUBING AND SHE WAS HOSPITALIZED LAST MONTH. CUSTOMER STATED WOULD DO PRIMING AND GOT COMPROMISED FORCE SENSOR SYSTEM. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660830 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 24 YR