BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972405 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05153
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY SCREEN.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THIS ALARM AND WAS UNABLE TO CLEAR THE ALARM. THE BLOOD GLUCOSE READING WAS 223 MG/DL. CUSTOMER ALSO REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER DID NOT REMEMBER THE BLOOD GLUCOSE READING AT THE TIME OF THE HOSPITALIZATION, BUT HE STATED THAT IT WENT VERY HIGH AFTER THE BUTTON ERROR AND DISCONNECTING FROM THE INSULIN PUMP. CUSTOMER WAS TREATED WITH AN INSULIN DRIP. CUSTOMER STATED THAT THIS WAS THE THIRD TIME HE HAD ENCOUNTERED A BUTTON ERROR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446761 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization