BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4151611 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34650
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A FAULTY GOLD FORCE SENSOR RESISTOR. THE BASIC OCCLUSION TEST AND OCCLUSION TEST COULD NOT BE PERFORMED DUE TO THE ALARM. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PROBLEMS WITH HER INSULIN PUMP. CUSTOMER STATED THAT HER BLOOD SUGAR WAS REALLY HIGH LAST NIGHT BECAUSE SHE THINKS THE PUMP WAS NOT WORKING. CUSTOMER ALSO STATED THAT LAST NIGHT, HER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CUSTOMER TOOK A MANUAL INJECTION. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 236 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HER HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE PUMP. CUSTOMER STATED THAT IT MAY HAVE BEEN BECAUSE SHE DROPS THE PUMP SOMETIMES. CUSTOMER DID NOT PRESS THE DRIVE SUPPORT CAP WHILE CONNECTED. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633339 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR