BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5566310 · Received April 10, 2016

    Report

    Report Number
    3004209178-2016-98176
    Event Type
    Injury
    Date Received
    April 10, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 5, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT ACT BUTTON RESPONSE DUE TO FLATTENED DOME. THE KEYPAD CONNECTOR WAS INSPECTED AND NO ANOMALIES NOTED. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS NO FAILED BATTERY TEST NOTED. THE INSULIN PUMP PASSED SELF-TEST, ERROR TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO REWIND ANOMALY NOTED. NO COSMETIC DAMAGE NOTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WILL NOT REWIND AND THE KEYPAD IS NOT RESPONSIVE. THE CUSTOMER INDICATED THAT HE IS UNABLE TO GET INTO THE MENU AS THE BUTTONS DO NOT WORK AND WAS UNABLE TO PERFORM THE SELF TEST. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 409 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221631 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 52 YR Other