BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4250682 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-51666
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO AN UNLOCKED KEYPAD CONNECTOR. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT A DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SCRATCHED RESERVOIR TUBE WINDOW. THE VISUAL INSPECTION VERIFIED THAT THERE WERE DOG CHEW MARKS ON THE RESERVOIR TUBE OPENING OF THE CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP FROZE WHEN PRIMING. IT WAS STATED THAT WHEN PRESSING THE ESC BUTTON THERE WAS NO RESPONSE. CUSTOMER'S LAST BLOOD GLUCOSE READING WAS 400 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 240 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736608 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 56 YR