BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203538 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-31659
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OFF NO POWER ALARM DUE TO CORRODED BATTERY TUBE. LOW BATTERY ALARM WAS NOT VERIFIED DUE TO OFF NO POWER ALARM ANOMALY. NO BLANK DISPLAY ANOMALY NOTED. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, BELT CLIP SLOT, MINOR SCRATCHED DISPLAY WINDOW.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY ON THE INSULIN PUMP WAS BLANK. THE CUSTOMER'S BLOOD GLUCOSE WAS 298 MG/DL. IT WAS ALSO STATED THAT A LOW BATTERY ALERT WAS RECEIVED AFTER FOUR HOURS AND AN OFF NO POWER ALERT OCCURRED LESS THAN 24 HOURS SUBSEQUENT TO THAT. THIS WAS REPORTED TO BE THE SECOND TIME TIME THE OFF NOW POWER ALERT OCCURRED WITHIN 24 HOURS OF THE LOW BATTERY ALERT. THE CUSTOMER REPORTEDLY STATED THE BATTERY WAS NOT PREVIOUSLY USED AND THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681622 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1