BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972312 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88688
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO CORRODED ELECTRONIC ASSEMBLY. NO CONSTANT TONE ALARM NOTED. UNABLE TO VERIFY BUTTON ERROR ALARM AND BATTERY OUT LIMIT DUE TO BLANK DISPLAY. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE INSULIN PUMP GOT WET. CUSTOMER DID NOT REMOVE THE INSULIN PUMP BEFORE ENTERING THE POOL. THE INSULIN PUMP KEPT BEEPING AND ALARM BATTERY OUT LIMIT. THE BLOOD GLUCOSE READING IS 406 MG/DL. CUSTOMER TREATED WITH BOLUS. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR DURING THE NIGHT. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447638 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR