BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5143328 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-55963
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CORRODED BATTERY TUBE; HOWEVER, THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. THE OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO COSMETIC DAMAGE NOTED.

    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

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE A BLANK SCREEN DISPLAY. CUSTOMER'S BLOOD GLUCOSE WAS 179 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT INSULIN PUMP SHOWED NO SIGNS OF PHYSICAL DAMAGE, INSULIN PUMP WAS NOT EXPOSED TO MOISTURE; CONTACTS ON BATTERY CAP WERE NOT MISSING; BATTERY COMPARTMENT WAS NOT DAMAGED OR CORRODED. AFTER TROUBLESHOOTING, DISPLAY SCREEN DID RETURN. INSULIN PUMP DID NOT COMPLETE SELF-TEST. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR