BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212060 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44971
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. NO FAILED BATTERY TEST ALARM NOTED. INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW AND RESERVOIR TUBE WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, BELT CLIP SLOT AND BATTERY TUBE THREADS.

    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

    CUSTOMER REPORTED THAT THEIR BUTTONS WERE STICKING ON THEIR INSULIN PUMP. THE CUSTOMER STATED, HE HAD EXPOSED HER INSULIN PUMP TO MOISTURE. THE CUSTOMER'S BLOOD GLUCOSE WAS 44 MG/DL. HE DECLINED TO TROUBLESHOOT FOR HIS BLOOD GLUCOSE. THE CUSTOMER ALSO STATED, HE ATTEMPTED TO ENTER HIS BLOOD GLUCOSE BUT HIS BUTTONS WERE UNRESPONSIVE. HE ALSO REPORTED RECEIVING A FAILED BATTERY TEST. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FORM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693249 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 26 YR