BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103392 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25266
    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
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 DURING TESTING. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES DURING THE VISUAL INSPECTION. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM AND STATED THAT SHE HAD WORN THE INSULIN PUMP IN THE BRA. SHE DID NOT RECALL THE BLOOD GLUCOSE READING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585105 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR