BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143440 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30065
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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). CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE PROTRUDED LOOSE DRIVE SPORT DISK. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY TESTS AND PRIME FILL ANOMALY. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED CASE AROUND DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LOOS DRIVE SUPPORT CAP O THE INSULIN PUMP, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER'S MOTHER CALLED AND STATED THAT HER DAUGHTER';S DRIVE SUPPORT CAP IS COMING OFF. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603473 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR