BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161932 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36130
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    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)

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CORRECTION WAS DONE TO REPORT THE SERIOUS INJURY UNDER THE INSULIN PUMP. FOLLOWING ADDITIONAL INFORMATION WAS ALSO PROVIDED IN REGARDS TO THE INSULIN PUMP. AT THE SAME TIME OF INITIAL CALL BUT WAS CAPTURED IN A SEPARATE SERVICE NOTIFICATION AND INCORRECT DEVICE: CUSTOMER REPORTED VIA PHONE CALL, SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 577 MG/DL AND THE INSULIN PUMP DIDN'T ALERT SHE WAS HIGH, AS IT SHOULD HAVE WHEN HER READING WAS OVER 300 MG/DL. CUSTOMER STATED THE SENSOR READING WAS 465 MG/DL. CUSTOMER TREATED THE HIGH WITH THE DEVICE AND MOST CURRENT BLOOD GLUCOSE WAS 170 MG/DL. CUSTOMER STATED ON (B)(6) 2014 SHE WAS ALSO HAVING SITE ISSUES WITH HER SENSOR AND THE METER READ HER BLOOD GLUCOSE AS HIGH AND SHE TREATED WITH MANUAL INJECTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER SENSOR WAS NOT GIVING ACCURATE READINGS. SHE ALSO STATED THERE WAS A CRACK NEAR THE BATTERY CAP ON HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL. THE CUSTOMER STATED SHE MAY HAVE BUMPED HER INSULIN PUMP. THE CUSTOMER ALSO REPORTED RECEIVING A LOW BATTERY ALARM THAT CAUSED HER INSULIN PUMP TO INCORRECTLY DELIVER INSULIN. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644896 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other