BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4081439 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21276
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE NO DELIVERY TEST DUE TO PRIME ANOMALY. INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. NO MOISTURE DAMAGE FOUND INSIDE THE INSULIN PUMP. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP AND MINOR SCRATCHED DISPLAY WINDOW.

    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.(B)(4)

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER REPORTED THAT THERE WAS FLUID UNDER THE DISPLAY OF THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A MOTOR ERROR AND NO DELIVERY ALARM FROM THE INSULIN PUMP ABOUT TWO WEEKS PRIOR TO THE EXPOSURE TO WATER. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561702 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR