BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974366 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89085
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 27, 2014
    Report Date
    January 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPEC AND PASSED FUNCTIONAL TESTING INCLUDING THE REWIND TEST, SELF-TEST, UNEXPECTED ALARM ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. HOWEVER, UNABLE TO DOWNLOAD UNIT TO CARELINK PRO DUE TO SEVERAL CORRUPTED HISTORY FILE ALARMS AT THE ALARM HISTORY FILE. CORRUPTED HISTORY FILE ALARMS DUE TO A CORRUPTED HISTORY FILE. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, STAINED ADDRESS/SERIAL NUMBER LABEL AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEIR INSULIN PUMP WAS UNABLE TO UPLOAD CALIBRATION INFORMATION. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE DEVICE HAD NO ALARM HISTORY. ADVISED CUSTOMER DEVICE WOULD NEED TO BE REPLACED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 147 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450281 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