BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945858 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87938
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND THE EXCESSIVE NO DELIVERY TEST DUE TO NO BUTTON RESPONSE. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY OR ON MOTOR.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ALARM ON HIS INSULIN PUMP. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 180 MG/DL OR 190 MG/DL AT THE TIME THE ISSUE WAS REPORTED. THE CUSTOMER ALSO STATED THAT THE ALARM MIGHT HAVE BEEN DUE TO MOISTURE BECAUSE HE WAS WORKING IN THE HOT ATTIC AND PERSPIRING PRIOR TO GETTING THE ALARM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426072 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 45 YR