BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4801288 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59915
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY TESTS. THE DEVICE HAD MINOR SCRATCHES ON THE LCD WINDOW, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND MISSING END CAP STICKER.

    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'S WIFE REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD SEVERAL NO DELIVERY ALARMS ON THE INSULIN PUMP. THE WIFE STATED THE ALARM WAS RESOLVED BY A COMPLETE SET CHANGE IN THE PAST. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL AT THE TIME OF INCIDENT. THE WIFE ALSO REPORTED RECEIVING A MOTOR ERROR ALARM DURING A BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 64 MG/DL AT THE TIME OF INCIDENT. THE WIFE COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE WIFE ALSO STATED THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE ON THEIR INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346800 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 46 YR