BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860664 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67706
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING OR SCROLLING DURING OR TESTING. THE INSULIN PUMP HAS CRACKED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, SHE THINKS THE INSULIN PUMP WAS FROZEN. CUSTOMER STATED SHE WAS ATTEMPTING TO BOLUS AND WHEN SHE ENTERING THE NUMBERS, THE DEVICE KEPT SCROLLING. SHE ATTEMPTED TO RESOLVE THE ISSUE BY REMOVING THE BATTERY A COUPLE OF TIMES BUT ANOMALY PERSISTED. CUSTOMER'S BLOOD GLUCOSE WAS 148 MG/DL. CUSTOMER DIDN'T RECALL ANY SIGNIFICANT EVENT WHICH MAY HAVE CAUSE THE DEVICE TO ALARM, HOWEVER SHE DOES KEEP THE DEVICE IN HER BRA. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. SHE AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402950 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR