BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945607 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04533
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    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 PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO DISPLAY RAMPING ON IT'S OWN ANOMALY NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    LT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A KEYPAD MALFUNCTION ON HIS INSULIN PUMP. THE NUMBERS ON THE SCREEN OF THE PUMP BEGAN TO RAMP UP WHILE HE WAS ABOUT TO BOLUS AND THE BUTTONS WERE NOT FUNCTIONING. THE CUSTOMER'S BLOOD GLUCOSE WAS 294 MG/DL. THE CUSTOMER WAS ADVISED TO DISSCONNECT FROM THE INSULIN PUMP AND HE STATED THAT AFTER HE DID SO, THE BUTTONS BEGAN TO WORK AGAIN. FURTHER ADVICE WAS GIVEN TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425087 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR