BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233968 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82790
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OBER 600 MG/DL. THE EVENTS LEADING TO HER ADMISSION WAS VOMITING AND KETONES. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST DAY. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 115 MG/DL, AND SHE HAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. THE CUSTOMER STATED THAT SHE HAD FALLEN WHILE WEARING THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED AD CUSTOMER DID NOT HAVE A REPLACEMENT OF THE BATTERY. THE CUSTOMER STATED THAT SHE IS NOT COMFORTABLE USING THE INSULIN PUMP AND REQUESTED A REPLACEMENT. THE CUSTOMER MENTIONED HAVING SEVERAL NO DELIVERY ALARMS. 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 39 YR Hospitalization PARADIGM: 9MM CATHETER| UNOMEDICAL INFUSION SET: MMT-397| QUICK-SET: 23