BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110554 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27392
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE OCCLUSION TEST AND WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. THE MOTOR PASSED THE MOTOR TEST. THE PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AFTER BOLUS DELIVERY. BLOOD GLUCOSE VALUE IS 300 MG/DL. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS ABLE TO COMPLETE THE REWIND SEQUENCE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592109 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL A5523NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR