BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211995 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-34367
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO BROKEN SOLDER JOINT OF POWER CONNECTOR ON INTERFACE BOARD. UNABLE TO VERIFY FAILED BATTERY TEST ALARM DUE TO BLANK DISPLAY. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    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 THAT SHE HAS BEEN CHANGING THE BATTERY ON THE INSULIN PUMP AND KEPT RECEIVING FAILED BATTERY TESTS AFTER A FEW HOURS AND THE BATTERY SYMBOL GOES BLANK. CUSTOMER STATED THAT THE CONTACTS ON BATTERY CAP ARE NOT MISSING OR DAMAGED AND THE BATTERY COMPARTMENT AND SPRING ARE NOT CORRODED. CUSTOMER WAS INSTRUCTED TO CLEAN THE BATTERY CAP AND REINSERT THE BATTERY; CUSTOMER RECEIVED A FAILED BATTERY TEST AGAIN. BLOOD GLUCOSE VALUE WAS 258 MG/DL; TREATED WITH MANUAL INJECTION. NOTHING FURTHER REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693231 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR