BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4033237 · Received August 25, 2014

    Report

    Report Number
    2032227-2014-10378
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD HAD CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED END CAP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S RECENT BLOOD GLUCOSE READING WAS 223 MG/DL. CUSTOMER REPORTED THE DEVICE WAS POSSIBLY EXPOSED TO HEAT AND HUMIDITY OR MOISTURE, AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE KEYPAD ISSUE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER STATED THE FIRST ALARM OCCURRED ABOUT A MONTH PRIOR TO CURRENT ALARM. CUSTOMER STATED THAT TIME SHE TOOK OUT BATTERY AND LET THE DEVICE COOL IN FROM OF THE AIR CONDITIONER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510828 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR