BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972289 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88716
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    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 REPORTED HOSPITALIZATION DUE TO HER LUNGS. CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS AT THE TIME OF THE HOSPITALIZATION WERE 500 MG/DL. CUSTOMER ALSO REPORTED RECEIVING MULTIPLE NO DELIVERY ALARMS AND HAVING TO CHANGE SETS SEVERAL TIMES TO CORRECT HER BLOOD GLUCOSE READINGS. CUSTOMER FURTHER STATED THAT SHE OCCASIONALLY NOTICES A BENT CANNULA AND EXPERIENCES HIGH BLOOD GLUCOSE READINGS CLOSE TO 300 MG/DL EVEN AFTER TAKING A BOLUS. CUSTOMER'S MOST RECENT BLOOD GLUCOSE READINGS ARE 142 MG/DL. CUSTOMER DECLINED ANY TROUBLESHOOTING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447316 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization