BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221708 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46652
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    May 5, 2013
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) 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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HAVING GASTROENTERITIS. CUSTOMER STATED THAT SHE HAD MAJOR STOMACH ACHES AND EXPERIENCED VOMITING AND DIARRHEA, THE PARAMEDICS HAD TO BE CALLED AND WAS TAKEN TO THE HOSPITAL. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER DECLINED TO TROUBLESHOOT AS SHE STATED THAT HER BLOOD GLUCOSE WAS NOT NECESSARILY HIGH AT THE TIME OF HOSPITALIZATION. CUSTOMER INITIALLY CALLED TO REPORT THAT SHE FOUND A LITTLE BLOOD IN HER INFUSION SET; CUSTOMER WAS UNABLE TO CHANGE AT THE TIME AS SHE DID NOT HAVE ANOTHER ONE AVAILABLE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702435 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET