BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3962137 · Received July 28, 2014

    Report

    Report Number
    2032227-2014-04872
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO CRACKED END CAP. NO MOTOR ERROR ALARM NOTED. HOWEVER, THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED THE TEST. NO LOOSE DRIVE SUPPORT DISK FOUND DURING VISUAL INSPECTION. THE UNIT WAS RECEIVED WITH SEVERELY CRACKED CASE ON DISPLAY WINDOW CORNERS, CRACKED LCD WINDOW, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR AND INSULIN WAS SQUIRTING OUT DURING FILL TUBING PROCEDURE. THE INSULIN PUMP ALSO ALARMED MOTOR ERROR DURING PRIMING. THE CUSTOMER STATED THAT THERE WAS A CRACK IN THE DEVICE. THE CUSTOMER'S BLOOD GLUCOSE WAS 80 MG/DL. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY ARE ABLE TO REWIND THE DEVICE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438109 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR