BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240454 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49710
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A STOMACH VIRUS LEADING TO A HIGH BLOOD GLUCOSE THAT SHE WAS HAVING DIFFICULTY LOWERING. THE CUSTOMER'S BLOOD GLUCOSE WAS 541 MG/DL AND SHE TREATED WITH MANUAL INJECTION. SHE STATED THAT SHE HAD BEEN VOMITING. THE CUSTOMER VISITED AN URGENT CARE WHERE SHE WAS TOLD TO EAT AND DRINK LIQUIDS AND EITHER RECEIVED OR WAS ADVISED TO USED THE ANTI-NAUSEA MEDICINE, ZOFRAN. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER'S INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER WAS UNSURE IF THE BASAL RATES WERE CORRECTED. HER BLOOD GLUCOSE WAS 458 MG/DL PRIOR TO ADMINISTERING A SECOND MANUAL INJECTION. THE CUSTOMER STATED THE CANNULA OF HER INFUSION SET LOOKED STRAIGHT AND NOT OCCLUDED. THE INSERTION SITE WAS NOT SORE OR IRRITATED. AT THE END OF TROUBLESHOOTING, THE CUSTOMER'S BLOOD GLUCOSE WAS 419 MG/DL. THE CUSTOMER FOLLOWED UP WITH HER HEALTHCARE PROVIDER REGARDING PROPER INSULIN PUMP SETTINGS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722197 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 75 YR Hospitalization