BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103347 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25190
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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

    ALL OF THE BUTTONS FUNCTIONED PROPERLY AND NO DAMAGE WAS NOTED ON THE KEYPAD ASSEMBLY. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, PRIME, BASIC OCCLUSION, AND OCCLUSION TEST. THE INSULIN PUMP PRIMED PROPERLY. NO UNLOCKED KEYPAD CONNECTOR WAS NOTED DURING THE VISUAL INSPECTION. 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.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY ARE CHANGING THEIR INFUSION SET AND ARE NOT SEEING ANY INSULIN DRIPS AT THE END OF THE TUBING. A BUTTON ERROR ALARM WAS NOTED IN THE ALARM HISTORY. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE READING WAS 450 MG/DL AT MIDNIGHT. CUSTOMER STATED THAT SHE MAY HAVE ROLLED ON THE INSULIN PUMP AND LAID ON THE BUTTONS. NO FURTHER INFORMATION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583903 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR