BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3943025 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87719
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE DEVICE 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

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE OF 20 MG/DL WHICH WAS TREATED WITH JUICE AND FOOD. PRIOR TO THE LOW BLOOD GLUCOSE THE CUSTOMER'S BLOOD GLUCOSE WAS 230 MG/DL. THE BOLUS WIZARD SETTINGS WERE CHANGED FROM 250 TO 260. THE CALLER STATED THAT SHE GAVE THE CUSTOMER A BOLUS AND WAS NOT SURE IF SHE OVER-BOLUSED. THE CUSTOMER WAS NOT HOSPITALIZED. THE DRIVE SUPPORT CAP WAS RECESSED. THE PROGRAMMING OF THE DEVICE WAS ACCURATE. THE RESERVOIR SHOWED LESS INSULIN THAN WHAT WAS DISPLAYED ON THE SCREEN OF THE INSULIN PUMP. THE DISPLACEMENT TEST PASSED.THE DEVICE WAS NOT EXPOSED TO STRONG MAGNETIC FIELD OR MRI. THERE WAS A CRACK ON THE LCD SCREEN OF THE DEVICE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419316 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR