BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3870881 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85705
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 19, 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
    GA
    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 BEING TREATED FOR LOW BLOOD GLUCOSE LEVELS BY PARAMEDICS. CUSTOMER STATES HAVING BLOOD GLUCOSE LEVEL OF 21 MG/DL AT TIME OF EVENT. PARAMEDICS TREATED PATIENT WITH GLUCOSE PILLS AND GLUCOSE GEL. CUSTOMER STATED THAT SHE WOKE UP AT 6:30 AND DOES NOT REMEMBER ANYTHING ELSE UNTIL THREE HOURS LATER WHEN SHE WAS ABLE TO CONTACT THE PARAMEDICS. SHE STATED THAT HER NEIGHBOR WHO HAS A KEY LET THEM IN; HER BLOOD GLUCOSE WAS 21MG/DL AND HER RESERVOIR WAS EMPTY. LATER ON THE DAY HER GLUCOSE LEVEL ROSE TO 400MG/DL. CUSTOMER DECLINED TROUBLESHOOTING AND STATED THE INSULIN PUMP APPEARS TO BE FUNCTIONING PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347148 530G INSULIN PUMP OYZ OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization