BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141708 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33280
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 HAD OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. NO FAILED BATTERY TEST ALARM WAS NOTED. THE LOW RESERVOIR TEST ALARM FEATURE WORKED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH A MISSING END CAP STICKER, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A FAILED BATTERY TEST ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 187 MG/DL. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER DID NOT RECEIVE A FAILED BATTERY TEST ALARM. CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP. CUSTOMER STATED THAT SHE HAS A SCRATCH ON THE SCREEN. INSULIN PUMP WILL NEED TO BE REPLACED DUE TO THE SCRATCH ON THE SCREEN. CUSTOMER ALSO STATED THAT SHE WAS HOSPITALIZED IN MARCH. CUSTOMER REPORTED THAT THERE WAS A CRACK ON THE SCREEN AND IT IS HARD FOR HER TO READ THE SCREEN WITH HER MAGNIFYING GLASS. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER WAS ADVISED THAT SHE WILL NEED TO GET A NEW BATTERY WITH THE NEW PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621375 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR