BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234003 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82779
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. MFG. REPORT 2 OF 2 MEDWATCH REPORT # 3004209178-2011-82780.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 470 MG/DL. THE CUSTOMER STATED THAT THE INFUSION SET WAS CHANGED SEVERAL TIMES WITHIN THE PAST TWENTY FOUR HOURS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND FOUND SEVERAL NO DELIVERY ALARMS. THE CUSTOMER STATED THAT THE ALARMS HAPPENED DURING HER BASAL AND BOLUS. ADVISED THE CUSTOMER THAT LOOKING THE BOLUS HISTORY THE HIGH BLOOD GLUCOSE WAS CAUSED BY THE NO DELIVERY ALARMS. INSTRUCTED THE CUSTOMER IF SHE IS NOT EATING, SHE SHOULD NOT ENTER IN CARBOHYDRATES REGARDLESS IF HER BLOOD GLUCOSE IS HIGH. EXPLAINED THE CUSTOMER THAT THE ACTIVE INSULIN IS ONLY TAKEN INTO ACCOUNT FOR A CORRECTION AND NOT FOR COVERING FOR FOOD. WHEN COMPARING THE DAILY TOTALS TO THE BASAL AND BOLUS HISTORY, IT SHOWED THE CUSTOMER INFUSES MORE INSULIN THAN THE DAILY TOTAL CALCULATED. NO FURTHER INFORMATION 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization QUICK-SET, 23| PARADIGM, 6MM CATHETER| UNOMEDICAL INFUSION SET, (B)(4)