BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981458 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06065
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. TRACES OF CORROSION FOUND AT ELECTRONIC ASSEMBLY. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THE INSULIN PUMP ALARMED FOR BUTTON ERROR. BLOOD GLUCOSE READING AT THE TIME WAS 107. THE CUSTOMER MENTIONED THAT SHE WENT SWIMMING WITH THE INSULIN PUMP ON. THE BUTTONS ON THE INSULIN PUMP ARE NOT RESPONDING. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457439 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR