BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3870904 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85707
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 CALLED IN TO REPORT HOSPITALIZATION FOR A BODY TEMPERATURE DROP AND SEIZURE BROUGHT ON BY LOW BLOOD GLUCOSE LEVELS. CUSTOMER STATED INSULIN PUMP ALARMED LOW INSULIN LEVELS BUT DID NOT HEAR IT. BLOOD GLUCOSE LEVEL WAS 30 MG/DL AT TIME OF HOSPITALIZATION AND WAS TREATED WITH INTRAVENOUS GLUCOSE DRIP AT HOME. OFFERED TROUBLESHOOTING BUT CUSTOMER DECLINED, STATING SHE BELIEVED INSULIN PUMP WAS FUNCTIONING PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347023 530G INSULIN PUMP OYZ OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization