BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM IN V2.2 SK EN

    MDR report key: 1842914 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-82829
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 500MG/DL. THE CUSTOMER STATED THAT SHE RECEIVED SEVERAL NO DELIVERY ALARMS AND CHANGED SEVERAL TIMES THE INFUSION SETS. THE CUSTOMER STATED THAT SHE WAS VERY SICK AND CONTACTED HER DOCTOR. THE CUSTOMER TRIED TO TREAT HER GLUCOSE LEVEL WITH THE INSULIN PUMP AND THE INSULIN PEN, AND THE BLOOD GLUCOSE KEPT RISING. THE PARAMEDICS WERE CALLED AND SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER STATED THAT SOMETIMES SHE USES THE INFUSION SETS MORE THAN THREE DAYS. ADVISED CUSTOMER TO CHANGE THE INFUSION SET EVERY TWO TO THREE DAYS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE CUSTOMER STATED THAT HER DOCTOR CHANGED THE INSULIN TYPE FROM NOVOLOG TO HUMALOG AND THE INSULIN PEN HAD NOVOLOG INSULIN. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM IN V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization