BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942846 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04466
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS. UNABLE TO CONFIRM BLANK DISPLAY ON INSULIN PUMP DUE TO CRACKED AND BLEEDING LCD GLASS.

    Additional Manufacturer Narrative · 1

    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DROPPED. THE BLOOD GLUCOSE READINGWAS 279 MG/DL. SHE TREATED WITH MANUAL INJECTIONS. CUSTOMER STATED THAT THE INFUSION SET DID NOT SHOW SIGNS OF DAMAGE. SHE STATED THAT THE SCREEN ONLY HAS A PARTIAL DISPLAY. IT WAS ALSO REPORTED THAT THE CUSTOMER RECENTLY HAD A BLOOD GLUCOSE READING OF 600 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419961 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR