BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141953 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32933
    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
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED KEYPAD ANOMALIES WERE NOTED. NO UNEXPECTED BUTTON ERROR ALARMS WERE NOTED AND THE BUTTONS ALL FUNCTIONED PROPERLY. HOWEVER, CORRODED KEYPAD TRACES WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A BROKEN RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS AND A BROKEN 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 HAD AN UNRESPONSIVE KEYPAD AND BUTTONS; THE BUTTONS WERE NOT RELEASING. LATER, DURING THE DAY, PRIOR TO THE PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 278 MG/DL. THE CUSTOMER STATED THAT THE REASON FOR THE HIGH BLOOD GLUCOSE WAS THAT THEY HAVE NOT HAD INSULIN FOR A COUPLE OF HOURS DUE THE ISSUED WITH THE DEVICE. THE CUSTOMER STATED THAT THE INSULIN PUMP MIGHT HAVE BEEN EXPOSED TO MOISTURE OR PERSPIRATION DUE TO HUMIDITY. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621528 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR