BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945802 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87956
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH LOUD VIBRATOR DURING SELF TEST DUE TO ADHESIVE BOND NOT ADHERING ON VIBRATOR MOTOR. NO KEYPAD ANOMALY NOTED. MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESREVOIR TUBE WINDOW THROUGH RESERVOIR TUBE, 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

    CUSTOMER REPORTED CRACKS ON HER INSULIN PUMP NEAR THE BATTERY AND RESERVOIR COMPARTMENTS AS WELL AS ON THE SCREEN OF THE INSULIN PUMP. CUSTOMER ALSO REPORTED THAT THE VIBRATE FEATURE IS MUCH LOUDER AND NOISIER THAN BEFORE. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE VIBRATE TEST AND THE SELF TEST. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE READINGS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425773 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR