BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240514 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49731
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND THAT SHE WAS UNSURE OF WHETHER HER INSULIN PUMP PROGRAMMING WAS CORRECT. THE BLOOD GLUCOSE READING WAS 55 MG/DL, WHICH WAS TREATED WITH JUICE. THE CUSTOMER NOTED THAT SHE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE SINCE THE DAY BEFORE THE CALL. THE BLOOD GLUCOSE READING WENT UP TO 99 MG/DL. SHE REPORTED THAT THE RESERVOIR DID SHOW THE SAME AMOUNT OF INSULIN AS WAS SHOWN ON THE STATUS SCREEN. AFTER REVIEWING THE PROGRAMMING ON THE DEVICE, SHE STATED THAT SHE WOULD CONTACT HER DOCTOR BECAUSE SHE WAS NOT SURE IF HER SETTINGS WERE CORRECT; SHE STATED THAT SHE WAS NOT AWARE OF THE PATTERN SETTINGS THAT HER DOCTOR HAD PROGRAMMED INTO THE DEVICE A FEW MONTHS PRIOR. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP AND CONSULT HER DOCTOR REGARDING THE LOW BLOOD GLUCOSE LEVELS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723489 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR