BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122370 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24861
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DISPLACEMENT TEST. HOWEVER, UNABLE TO PRIME UNIT DURING THE PRIMETEST DUE TO FAULTY FORCE SENSOR. UNABLE TO TEST EXCESSIVE NO DELIVERY DUE TO FAULTY FORCE SENSOR. NO UNEXPECTED NO DELIVERY ALARMS NOTED. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW AND A CRACKED CASE AT DISPLAY WINDOW CORNERS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED A NO DELIVERY ALARM BUT WAS UNABLE TO TROUBLESHOOT FOR THE ISSUE AS HE WAS ADVISED TO DISCONTINUE USING THE INSULIN PUMP BY HIS DOCTOR. THE BLOOD GLUCOSE READING WAS 300 MG/DL. HE REPORTED THAT HE WAS RECEIVING THESE ALARMS EVERY NIGHT. HE STATED THAT THE ISSUE WAS NOT RESOLVED BY TRYING DIFFERENT CANNULA LENGTHS, CHANGING THE RESERVOIR, OR CHANGING THE INFUSION SET. HE STATED THAT THE INSULIN WAS NOT DENATURED OR EXPIRED. HE STATED THAT THE TUBING WAS NOT BENT OR KINKED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579317 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR