BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181273 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39517
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    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 PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5. 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE WAS UNSURE WHAT WAS GOING ON WITH HIS INSULIN PUMP. THE BLOOD GLUCOSE READINGS WERE BETWEEN 500 TO 600 MG/DL SINCE THE PREVIOUS DAY, AND THE CUSTOMER NOTED HE HAD CHANGED HIS INSERTION SITE THE NIGHT BEFORE THE CALL. HE STATED THAT HIS BLOOD GLUCOSE LEVELS STAYED HIGH THROUGHOUT THE DAY, AND BY AFTERNOON IT WAS 289 MG/DL. AFTER EATING, THE BLOOD GLUCOSE READING CONTINUED TO LOWER TO ABOUT 220 MG/DL. HE ATE DINNER, PERFORMED A DUAL BOLUS, AND FOUND THE BLOOD GLUCOSE READING AT 179 MG/DL. BY MORNING THE NEXT DAY AROUND 4 AM, THE BLOOD GLUCOSE READING ROSE TO OVER 600 MG/DL, LOWERED TO 590 MG/DL, AND STAYED IN THE 500 MG/DL RANGE SINCE THEN. TROUBLESHOOTING FOUND THAT THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660764 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR