BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3253312 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96199
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY. NO BUTTON ERROR ALARMS NOTED. HOWEVER, MOISTURE DAMAGE WAS NOTED ON KEYPAD TRACES DURING VISUAL INSPECTION. UNABLE TO PRIME DURING PRIME TEST DUE TO MOISTURE DAMAGE NOTED IN FORCE SENSOR. UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. THE INSULIN PUMP PASSED DISPLACEMENT TEST. MISSING END CAP STICKER NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SUDDENLY HER INSULIN PUMP STOPPED WORKING, AND THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE OVER 410MG/DL. THE CUSTOMER MENTIONED BEING OFF THE INSULIN PUMP FOR TWO HOURS WITHOUT TREATING AFTER EATING. DURING THE CALL, THE CUSTOMER MENTIONED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 30S OR 40S MG/DL ON (B)(6), 2013. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER WAS UNABLE TO DESCRIBE ANY POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP. THE CUSTOMER BELIEVES THAT SHE HAD OVER CORRECTED AND DID NOT EAT ENOUGH TO COVER THE BOLUS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353965 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization