BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202499 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82445
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF OVER 600MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING AND DEHYDRATED. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST TWO DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 180MG/DL, AND HE HAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE RESERVOIR WAS STILL IN THE INSULIN PUMP AND DISPLAYED A MESSAGE TO COMPLETE THE MANUAL PRIME. ASSISTED WITH REWIND PROCESS, AND INSTRUCTED THE CALLER TO REMOVE AND INSERT THE RESERVOIR INTO THE INSULIN PUMP. RAN A FIXED PRIME TEST AND THE INSULIN PUMP DID NOT PASS THE TEST. REVIEWED THE ALARM HISTORY AND SHOWED BUTTON ERROR ALARMS. ADVISED THE CALLER THAT THE CUSTOMER SHOULD 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization PARADIGM, 9MM CATHETER| QICK-SET, 23| UNOMEDICAL INFUSION SET, MMT-397