BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5062555 · Received September 8, 2015

    Report

    Report Number
    2032227-2015-40680
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 9, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY WERE HOSPITALIZED FOR THREE DAYS STARTING ON (B)(4) 2015 AT 9:00 AM WITH A HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. THE CUSTOMER DID NOT MENTION ANY FORM OF TREATMENT FOR THEIR BLOOD GLUCOSE LEVELS. THE CUSTOMER CALLED REQUESTING A NEW BELT CLIP. THE CUSTOMER MENTIONED THAT THEY WERE LAYING ON THE FLOOR PRIOR TO THE HOSPITALIZATION. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING THE EXACT CAUSE OF THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS WEARING THEIR INSULIN PUMP DURING THEIR HOSPITAL STAY. THE CUSTOMER DID NOT RETURN THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594316 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization