BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200227 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23962
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    April 16, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE DISPLACEMENT. DEVICE RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND CRACKED CASE DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DESTROYED IN AN AUTO ACCIDENT IN WHICH SHE WAS NOT THE DRIVER. CUSTOMER STATED THAT THE INSULIN PUMP WAS SMASHED AND SHE WAS UNSURE IF SHE WOULD BE ABLE TO RETRIEVE ANY PART OF IT. BLOOD GLUCOSE LEVEL WAS 187 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR