BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2101563 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81546
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 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
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 1140 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, HE HAD A HEART ISSUE THAT RESULTED FROM THE DIABETIC KETOACIDOSIS AND THAT HE HAD BEEN HAVING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST WEEK. FURTHERMORE, THE CUSTOMER STATED THAT HE HAD ALREADY BEEN HOSPITALIZED BEFORE WITHIN THE LAST THREE MONTHS BEFORE THE EVENT. THE CUSTOMER ALSO STATED THAT HE LAST CHANGED HIS INFUSION SET THE NIGHT BEFORE THE EVENT AND THAT HE USES A QUICK-SET INFUSION SET. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME. NOTHING FURTHER WAS REPORTED.

    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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization MODEL MMT-399| UNOMEDICAL QUICK-SET INSULIN INFUSION SET,