BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190356 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82342
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS. THE CUSTOMER CLEARED THE ALARM AND DELIVERED A BOLUS, BUT THE INSULIN PUMP ALARMED AGAIN. THE CUSTOMER STATED THAT SHE HAD SYMPTOMS OF DIABETES KETOACIDOSIS AND WENT TO THE HOSP. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP PASSED THE TEST. PERFORMED A SELF TEST AND PASSED. THE INSULIN PUMP REWINDS AND PRIME MANUALLY. 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization