BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183089 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40092
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 10, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 MANY TIMES DUE TO DIABETIC COMPLICATIONS. SINCE A REPORTED HOSPITALIZATION ON (B)(6) 2014, THE CUSTOMER WAS ADMITTED INTO THE HOSPITAL ON THE FOLLOWING DATES: (B)(6) 2014. THE FIRST 2 WERE FOR DIABETIC KETOACIDOSIS, AND THE THIRD WAS FOR LOW BLOOD GLUCOSE AND GASTROPARESIS. DURING THE HOSPITALIZATION OF (B)(6) 2014, THE BLOOD GLUCOSE READING WAS 600 MG/DL. THE CUSTOMER WAS VOMITING AND HAD KETONES. THE CUSTOMER STATED THAT SHE HAD BEEN IN 4 CAR ACCIDENTS IN THE PAST 6 MONTHS; SHE STATED THAT PEOPLE KEPT CRASHING INTO HER WHILE SHE WAS PARKED. SHE DID NOT REMEMBER IF SHE HAD BEEN IN A CAR ACCIDENT PRIOR TO THE 3 HOSPITALIZATIONS SHE REPORTED. SHE STATED THAT SHE HAD HIGH BLOOD GLUCOSE LEVELS TRIGGERED BY STRESS FROM DEALING WITH MEDTRONIC. THE MOST RECENT BLOOD GLUCOSE READING WAS 370 MG/DL. SHE SAID SHE WOULD BE VOMITING SOON. SHE DECLINED AN OFFER TO CALL EMERGENCY MEDICAL TECHNICIANS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660480 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization