BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143385 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29843
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    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 THAT HER BLOOD GLUCOSE HAVE BEEN RANGING FROM THE AROUND 30 MG/DL TO OVER 400 MG/DL. CUSTOMER STATED THAT THE BUTTONS ON THE INSULIN PUMP OCCASIONALLY DON'T RESPOND. DEVICE GOT WATER SPLASHED WHILE DOING THE DISHES. CUSTOMER STATED THAT WHEN SHE HAS REMOVED INFUSION SETS THAT HER CANNULA IS NOT BENT. CURRENT BLOOD GLUCOSE VALUE IS 161 MG/DL. CUSTOMER STATED SHE HAS A BACKUP PLAN AND HAS NOT TREATED. THE DEVICE HAS A SMALL CRACK ON THE SCREEN AREA. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. CUSTOMER STATED THE TUBING HAS NO AIR BUBBLES. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME; INSULIN DID EXIT THE TUBING. CUSTOMER DID NOT FIND AN INSULIN LEAK. BOLUS HISTORY IS ACCURATE. CUSTOMER STATED THAT TIME, DATE, BASAL RATES AND BOLUS WIZARD ARE SETUP CORRECTLY. INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603710 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAP A000208216

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR