BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142325 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33688
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 522 MG/DL, BOLUSING, GOING DOWN TO 200 MG/DL, BUT THEN RISING TO A BLOOD GLUCOSE LEVEL OF OVER 600 MG/DL LATER THAT DAY. CUSTOMER WAS DIAGNOSED AS HAVING HAD A HEART ATTACK AND WAS HOSPITALIZED. BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF ADMISSION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621868 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization