BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143327 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29083
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTION PROPERLY DURING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO MOTOR ERROR OR EXCESSIVE NO DELIVERY ALARMS NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 212 MG/DL. CUSTOMER STATED THAT THE ALARM HAPPENED BEFORE. CUSTOMER'S BLOOD GLUCOSE WAS AT 515 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION OF 10 UNITS. CUSTOMER STATED THAT THE INSULIN DID EXIT. CUSTOMER WAS ABLE TO REMOVE THE SET TO EXAMINE THE CANNULA. CUSTOMER REPORTED THAT THE CANNULA IS NOT BENT. IT WAS EXPLAINED THAT THE SITE MAY HAVE BEEN OCCLUDED. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET AND RETURN THE SET FOR ANALYSIS. IT WAS ALSO EXPLANTED THAT THERE MIGHT BE AN ISSUE BETWEEN THE CONNECTION TAPED AND THE CONNECTION INSERTED. CUSTOMER DID A BOLUS AND A FEW UNITS WENT IN AND THEN HE GOT THE NO DELIVERY ERROR. ON (B)(6) 2014, CUSTOMER CALLED BACK AND GOT A MOTOR ERROR ON THE PUMP. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603319 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR