BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103579 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26669
    Date Received
    September 19, 2014
    Date of Event
    August 20, 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
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE INSULIN PUMP WAS RECEIVED WITH BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED CASE AT DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER DID NOT KNOW BLOOD GLUCOSE LEVEL. CUSTOMER STATED THE DEVICE WAS CRACKS IN THE RESERVOIR COMPARTMENT AND IT WAS MISSING CHUNKS. CUSTOMER STATED THE DAMAGE WAS TO THE OPEN END OF THE COMPARTMENT AND THE OUTER RIM WAS MISSING BIG CHUNKS. CUSTOMER STATED THE DAMAGED OCCURRED BECAUSE OF NORMAL WEAR AND TEAR. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584338 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR