BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233694 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49205
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 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

    (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 FOR LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 43 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT AT FAULT. HE NOTED THAT HE HAD STUBBED HIS TOE THE NIGHT PRIOR AND THAT IT BEGAN SWELLING. HE REPORTED THAT HE WAS HOPPING, EXERTING ADDITIONAL ENERGY TO GET TO HIS VEHICLE. HE STATED THAT HE GRABBED A MEAL, INTENDED TO EAT, BUT MADE A CALL INSTEAD. HE THEN REPORTED THAT HE DOZED OFF FOR A BIT AND WHEN HE CAME TO, EMERGENCY MEDICAL SERVICES WERE TENDING TO HIM ON SITE. HE BELIEVED THAT THE CAUSE OF HIS LOW BLOOD GLUCOSE LEVELS WAS HIS FAILING TO EAT TO COMPENSATE FOR HIS EXPENSE OF ENERGY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715622 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention