BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182608 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39706
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 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
    ME
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TEST. ALL OF THE BUTTONS FUNCTIONED PROPERLY DURING TESTING. NO DAMAGE WAS NOTED ON THE KEYPAD ASSEMBLY AND NO UNLOCKED KEYPAD CONNECTOR WAS NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND A 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE AND INSULIN PUMP BUTTONS WERE UNRESPONSIVE. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. CUSTOMER STATED THAT CARBS WAS INPUTTED AND THE INSULIN PUMP GAVE THE SAME AMOUNT OF INSULIN. CUSTOMER STATED HAD A LOW BLOOD GLUCOSE OF 25 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660442 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 16 YR