BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240100 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49815
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY, HOWEVER CORRODED KEYPAD TRACES NOTED DURING VISUAL INSPECTION. INSULIN PUMP HAD A CRACKED LCD WINDOW, CRACKED CASE ON LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED BELT CLIP SLOT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE AND HAD PHYSICAL DAMAGE. CUSTOMER STATED THAT WHEN HE WAS TRYING TO GIVE HIMSELF BOLUS THE BUTTONS DID NOT WORK AND HAD SCRATCHED SCREEN. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 350 MG/DL. CUSTOMER STATED HAS NOT TREATED YET BUT WILL BE GIVING INJECTION. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723399 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 66 YR