BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182796 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02558
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DETACHED END CAP, MISSING END CAP STICKER, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND CRACKED CASE NEAR RESERVOIR WINDOW NOTED DURING VISUAL INSPECTION. DRIVE SUPPORT DISK WAS INSPECTED AND MISSING DRIVE SUPPORT DISK STICKER WAS NOTED. DRIVE SUPPORT DISK WAS NOT LOOSE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE END CAP AND DRIVE SUPPORT CAP WERE PROTRUDING FROM THE CASE. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 99 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283215 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR