BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233750 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49202
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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 HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 891 MG/DL AT THE TIME OF ADMITTANCE. THE CUSTOMER STATED THAT SHE WAS THROWING UP AND COULD NOT KEEP HER BLOOD GLUCOSE LEVELS UNDER CONTROL. SHE WAS TREATED AND DISCHARGED. SHE DECLINED TROUBLESHOOTING AFTER HAVING BEEN HOSPITALIZED, STATING THAT SHE REALIZED THAT HER SETTINGS WERE INCORRECT AND THAT THEY HAD BEEN CORRECTED SINCE SHE SWITCHED DOCTORS. SHE NOTED THAT SHE HAD GONE TO THE DOCTOR 2 DAYS PRIOR TO THE HOSPITALIZATION WITH A BLOOD GLUCOSE READING OF 502 MG/DL AND WAS TOLD SHE WAS FINE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714596 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization UNOMEDICAL INFUSION SET