BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141025 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-31796
    Event Type
    Injury
    Date Received
    October 3, 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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. THE DEVICE PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, NO DELIVERY AND MOTOR TESTS. NO EXCESSIVE "NO DELIVERY" ALARM OR MOTOR ERROR ALARM NOTED. HOWEVER, THE DEVICE HAD MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 366 MG/DL. THEY WERE FEELING FLUSH, HAD KNEE PAIN AND RED FACE. THE CUSTOMER WAS REPORTING AN ISSUE WITH THE RESERVOIR AND STATED THAT THEY WERE NOT CONNECTED TO THE INSULIN PUMP AT THE TIME OF THE PHONE CALL. THEIR BLOOD GLUCOSE WAS 296 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT SEVERAL WEEKS AGO THEY HAD PERFORMED TROUBLESHOOTING. THEY CHANGED THE INFUSION SET INSERTION SITE, BUT THE INSULIN PUMP HAD ALARMED NO DELIVERY. THE CUSTOMER DOES NOT ROTATE THE SITE AND INSERTS THE SET MANUALLY. THE CUSTOMER DID NOT HAVE SCAR TISSUE. THE INSULIN PUMP HAD ALSO ALARMED MOTOR ERROR. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER STATED THAT THERE WAS A JAMMING; IT WAS DIFFICULT TO PLACE THE RESERVOIR INTO THE INSULIN PUMP. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618742 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization