BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143333 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30029
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLANK DISPLAY ON THE INSULIN PUMP. CUSTOMER WAS WALKED THROUGH THE PROCESS OF PRIMING THE PUMP. CUSTOMER STATED THAT SHE WILL GIVE A BOLUS AND ONLY A FEW UNITS WILL BE ADMINISTERED, THEN THE BLANK DISPLAY APPEARS. CUSTOMER JUST PUT A NEW BATTERY IN THE PUMP AND CAME HOME FROM THE HOSP ON THE 25TH. CUSTOMER WAS NOT HOSPITALIZED FOR A DIABETIC RELATED CONDITION. CUSTOMER STATED THAT THE DISPLAY RETURNED AFTER A NEW AAA ALKALINE BATTERY WAS INSERTED INTO THE PUMP. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603443 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization