BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2243756 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82362
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 238 MG/DL, AND HE WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND IT SEEMS THAT ALL THE SETTINGS WERE CORRECT. THE CUSTOMER STATED THAT THE INFUSION SET AND RESERVOIR ARE CONNECTED PROPERLY, BUT HE DID NOTICE LIKE THE RESERVOIR, IT MAY NOT BE A GOOD FIT. RAN A FIXED PRIME AND PASSED. PERFORMED A HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP FAILED THE TEST. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR