BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873349 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85782
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT HE WAS AT A DINNER PARTY WHEN HIS BLOOD GLUCOSE LEVEL WENT LOW, 30 MG/DL. THE PREDICT LOW ALERT DID NOT ALERT CUSTOMER HE WAS GOING LOW UNTIL IT WAS ALREADY AT 30 MG/DL AND PARAMEDICS HAD BEEN CALLED. THE PARAMEDICS RAISED CUSTOMER'S BLOOD GLUCOSE TO 57 MG/DL AND RELEASED HIM. CUSTOMER ALSO STATED THAT SOMETIMES HIS BLOOD GLUCOSE READING IS OFF BY 100 MG/DL, AND THAT HE USUALLY GETS PREDICT ALERTS ALL NIGHT. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 91 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349585 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention