BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4140852 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33189
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS PROVIDED TO CORRECT THE EVENT DETAILS IN SECTION B5 OF OUR ORIGINAL MEDWATCH FORM, WHICH STATED THAT THE CUSTOMER HAD A BLOOD GLUCOSE READING OF 307 MG/DL.

    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 LOW BLOOD GLUCOSE LEVELS, WHICH REQUIRED MEDICAL INTERVENTION BY EMERGENCY MEDICAL TECHNICIANS. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING WAS WELL BELOW 40 MG/DL AND SHE DID NOT RECALL WHAT HAPPENED. SHE STATED THAT THE INSULIN PUMP WAS ALARMING AND SHE WAS HAVING A REACTION. SHE STATED THAT HER DOG WOKE HER DAUGHTER UP, AND HER DAUGHTER FOUND HER HAVING A SEIZURE AND FOAMING AT THE MOUTH. THE CUSTOMER'S SON WOKE UP, TREATED HER WITH 2 GLUCAGON SHOTS, AND CALLED 911. THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS 70 MG/DL WHEN SHE AWOKE. SHE STATED THAT SHE HAD ACCIDENTALLY GIVEN HERSELF 9.7 UNITS OF INSULIN WHEN HER BLOOD GLUCOSE READING WAS 307 MG/DL, THEN ANOTHER 9.9 UNITS 17 MINUTES LATER. SHE STATED SHE WAS UNAWARE OF WHAT SHE WAS DOING. NO PERCEIVED CAUSE OF THE EVENT WAS NOTED AS THE CUSTOMER WAS IN A HURRY TO END THE CALL. NOTHING FURTHER REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS SO LOW THAT SHE WAS UNAWARE OF WHAT SHE WAS DOING AND ACCIDENTALLY DELIVERED 9.7 UNITS OF INSULIN AT 3:07 AND THEN ANOTHER 9.9 UNITS 17 MINUTES LATER, WHILE SHE WAS TRYING TO CHECK THE BLOOD GLUCOSE READING ON THE INSULIN PUMP. CUSTOMER REPORTED THAT NOTHING LIKE THIS HAD HAPPENED FOR THE 14 YEARS THAT SHE HAD BEEN USING THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619697 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention