BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945081 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87757
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WOKE UP IN THE MORNING WITH HIGH BLOOD GLUCOSE, WHICH USUALLY HAPPENS A DAY AFTER THE CUSTOMER CHANGES THE SET. CUSTOMER CONFIRMED THAT SHE HAD THIS PROBLEM 2 MONTHS AGO. THE INSULIN PUMP ALARMED WITH HIGH BLOOD GLUCOSE DETECTED BUT THE CUSTOMER IS UNABLE TO HEAR IT AT NIGHT. THE CUSTOMER MENTIONED THAT SHE ALSO EXPERIENCED LOW BLOOD GLUCOSE; SHE DID NOT EXHIBIT ANY SYMPTOMS AND TREATED BY DRINKING JUICE TO CORRECT. UNABLE TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE BECAUSE THE CUSTOMER DID NOT HAVE HER RATES. THE CUSTOMER CALLED AGAIN STATING THAT SHE NEEDED TO MAKE SURE HER SETTINGS ON THE INSULIN PUMP WERE RIGHT. THE BLOOD GLUCOSE READING WAS 115 MG/DL. UPON TROUBLESHOOT BY MANUAL PRIME, IT WAS FOUND THAT INSULIN DID EXIT THE TUBING AND NO LEAKS WERE FOUND. BOLUS HISTORY SETTINGS WERE CORRECT. UNABLE TO COMPLETE TROUBLESHOOT DUE TO LACK OF TEST SUPPLIES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421510 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR