BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4000312 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-90226
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE, BATTERY TUBE THREADS, SEVERE SCRATCHES ON DISPLAY WINDOW AND NO CRACKS AT DISPLAY WINDOW NOTED.

    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

    IT IS REPORTED THAT THE PATIENT HAS A CRACKED INSULIN PUMP. THEIR BLOOD GLUCOSE LEVEL IS AT 89MG/DL. TROUBLE SHOOTING DETERMINED THE DEVICE WAS DROPPED. PATIENT ADVISED TO CEASE USE OF DEVISE AND SWITCH TO BACKUP. PUMP IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477156 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR