BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5653946 · Received May 13, 2016

    Report

    Report Number
    3004209178-2016-46847
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    March 19, 2014
    Report Date
    March 19, 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
    OTHER

    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. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE HAS BEEN HAVING LOW BLOOD GLUCOSE FOR THE PAST FEW DAYS. CUSTOMER STATED THAT HE STARTED DOING A LOT OF CARDIO AND NOTICED THAT HIS BLOOD GLUCOSE WAS DROPPING, ESPECIALLY AFTER 2 HOURS AFTER DOING A BOLUS. CUSTOMER STATED THAT HIS HEALTH CARE PROFESSIONAL IS OUT OF THE OFFICE, SO HE WANTS TO LOWER THE SETTINGS. CUSTOMER'S BLOOD GLUCOSE IS 48 MG/DL. CUSTOMER TREATED WITH A PROTEIN BAR. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR 2 DAYS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER STATED THAT HE HAS GREATLY INCREASED HIS CARDIO WORKOUTS. CUSTOMER WAS ADVISED TO SPEAK TO HIS HEALTH CARE PROFESSIONAL REGARDING LOW BLOOD GLUCOSE. CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND HIS BLOOD GLUCOSE UNTIL THE SETTINGS ARE ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307431 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other