BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2232439 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-82694
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BEING HOSPITALIZED. THE CUSTOMER STATED THAT SHE DID NOT TREAT FOR TWELVE HOURS BECAUSE THE CANNULA WAS CRIMPED AND HER GLUCOSE LEVEL WENT UP. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING WAS 590MG/DL. THE CUSTOMER STATED THAT THE EVENTS LEADING TO HER ADMISSION WAS CONFUSION, FLU SYMPTOMS, TROUBLE BREATHING, AND TIGHTNESS IN CHEST. THE CUSTOMER CALLED BACK AND REPORTED THAT THE INSULIN PUMP DID NOT ALARM WHEN THE RESERVOIR WAS EMPTY. THE CUSTOMER STATED HAVING HIGH BLOOD GLUCOSE OF 426MG/DL AFTER HAVING 53MG/DL AND EATING BREAKFAST WITHOUT TREATING. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE TEST FAILED. DURING THE CALL THE CUSTOMER MENTIONED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE (B)(6). ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND 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-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization