BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181272 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39515
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE BLOOD GLUCOSE READING WAS 300 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER STATED THAT HE HAD RECEIVED NO DELIVERY ALARMS 3 DAYS PRIOR, EXPERIENCING RISING BLOOD GLUCOSE LEVELS, WENT INTO DIABETIC KETOACIDOSIS, AND WAS VOMITING. HE COMPLAINED OF DEHYDRATION FROM HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME OF THE NO DELIVERY ALARM WAS 367 MG/DL. UPON TROUBLESHOOTING, INSULIN DID EXIT DURING A FIXED PRIME, AND HE WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET DUE TO A POSSIBLE SITE OR SET-RELATED OCCLUSION. UPON ADMITTANCE TO THE HOSPITAL, THE CUSTOMER WAS TREATED WITH FLUIDS AND MANUAL INJECTIONS, AND HE WAS DISCHARGED AFTER HIS BLOOD GLUCOSE LEVELS WERE STABILIZED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660907 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization