BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4202651 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-24020
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY, MOTOR OR AT THE CRACK. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4)MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 156 MG/DL. CUSTOMER REPORTED THE DEVICE HAD LITTLE CRACKS ON THE DEVICE AND THEY SPREAD AND THERE WAS MOISTURE ON THE CRACKS, AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576634 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR