BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103708 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25426
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5. 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 BUTTON ERROR. THE CUSTOMER DID NOT KNOW THE BLOOD GLUCOSE READING. SHE STATED THAT SHE HAD KEPT THE INSULIN PUMP IN HER BRA BUT WAS UNSURE WHETHER SHE HAD GOTTEN SWEAT ON IT. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582223 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR