BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933110 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86953
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. OFF NO POWER ALARM DID FUNCTION PROPERLY AND PASSED THE SELF TEST. NO UNEXPECTED FAILED BATTERY TEST ALARM NOTED. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, MISSING END CAP STICKER 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE PUMP ALARMED A FAILED BATTERY TEST. SHE STATED THAT THE BATTERY HAS BEEN REPLACED FIVE TIMES. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE SPRING ON THE BATTERY CAP WAS CORRODED. THE CUSTOMER'S MOTHER SECURELY FASTENED A NEW BATTERY AND THE PUMP DID NOT ALARM FAILED BATTERY. THE CURRENT BLOOD GLUCOSE READING WAS 220 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410971 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR