BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4130693 · Received September 30, 2014

    Report

    Report Number
    2032227-2014-31185
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER, LOW BATTERY OR FAILED BATTERY TEST ALARMS WERE NOTED. THE INSULIN PUMP PASSED FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS IN A BIKE ACCIDENT AND HER BLOOD GLUCOSE WAS HIGH AND THE CUSTOMER RECEIVED A FAILED BATTERY TEST ALARM ON HER INSULIN PUMP. HER BLOOD GLUCOSE WAS 308 MG/DL, WHICH SHE TREATED WITH A BACK-UP INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE FAILED BATTERY TEST WAS RESOLVED WITH A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE, AS WELL. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR BUBBLES WERE NOTICED IN THE TUBING. THE CUSTOMER STATED SHE DID NOT NOTICE A LEAK. THE OLD SET HAD BEEN THROWN AWAY. WHILE THE CUSTOMER WAS IN THE HOSPITAL DUE TO THE BIKE ACCIDENT, SHE REPORTEDLY HAD TESTS RUN WHILE SHE WAS WEARING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607271 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization