BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240509 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49725
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 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
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD CRACKED AND BLEEDING DISPLAY GLASS. NO BLANK DISPLAY OR AUDIO ANOMALIES COULD BE VERIFIED DUE TO THE DAMAGED DISPLAY GLASS. THE INSULIN PUMP HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER AND A CRACKED END CAP.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). 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 WAS REPORTED THAT THE INSULIN PUMP HAD A BROKEN SCREEN AND SOUNDED A CONTINUOUS BEEP. THE BLOOD GLUCOSE READING WAS 180 MG/DL. THE CUSTOMER STATED THAT HE ATTEMPTED TO RESOLVE THE ISSUE WITH A BATTERY CHANGE, BUT THE INSULIN PUMP WOULD NOT TURN ON ANY LONGER. HE NOTED THAT HE HAD FALLEN OFF OF HIS BIKE AND CRACKED THE SCREEN, AS WELL AS ANOTHER PART OF THE INSULIN PUMP. HE OBSERVED THE CRACK RIGHT ABOVE THE UP ARROW BUTTON AND AT THE CORNER OF THE DISPLAY SCREEN. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723577 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR