BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181269 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39514
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS, WHICH REQUIRED MEDICAL INTERVENTION. THE BLOOD GLUCOSE READING WAS IN THE 500 MG/DL RANGE. THE CUSTOMER STATED THAT SHE BOLUSED AND RECEIVED A NO DELIVERY ALARM. SHE CHANGED THE BATTERY AND INFUSION SET, THEN TREATED WITH A MANUAL INJECTION. THE BLOOD GLUCOSE READING THEREAFTER 368 MG/DL. SHE STATED SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS WITH A READING OF 40 MG/DL. EMERGENCY MEDICAL SERVICES TREATED HER ON THE SCENE, AND SHE WAS TAKEN TO THE HOSPITAL. SHE STATED THAT SHE HAD FALLEN OFF THE COUCH PRIOR TO THE 911 CALL. SHE WAS UNSURE WHAT THE PERCEIVED CAUSE OF THE LOW BLOOD GLUCOSE BUT MENTIONED THAT SHE WAS PREMENOPAUSAL. AFTER DISCHARGE, THE SETTINGS ON THE DEVICE WERE ADJUSTED, AND IT WAS WORKING AS DESIGNED. THE CALLER ALSO REPORTED ISSUES WITH THE SENSOR TRIGGERING ALARMS, BUT IT WAS UNCLEAR WHICH SENSOR ALARMS OCCURRED. SHE DID NOT UNDERSTAND THE TECHNOLOGY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660906 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization