BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3841700 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85238
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    THE CUSTOMER CALLED IN TO REPORT THAT SHE HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER RECALLS THAT THE SIGNIFICANT EVENTS LEADING UP INTO THE HOSPITALIZATION WERE THAT SHE TOOK GLUCOSE TABLETS FOR LOW BLOOD GLUCOSE AND PASSED OUT. CUSTOMER'S HUSBAND CALLED THE PARAMEDICS. DURING TROUBLESHOOTING THE CUSTOMER SAID THAT THE BOLUS WIZARD SETTING APPEARED TO BE INACCURATE. CUSTOMER ALSO STATED THAT THE INSULIN PUMP OVER-DELIVERED INSULIN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319491 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization