BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132190 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31012
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    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

    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

    CUSTOMER REPORTED HER INSULIN PUMP ALARMED NO DELIVERY. SHE DISCONNECTED AND RECONNECTED AND REWOUND THE DEVICE, BUT IT ALARMED NO DELIVERY AGAIN. SHE DISCONNECTED AND RECONNECTED AGAIN AND NOW IT ALARMED MOTOR ERROR. CUSTOMER STATED THE DEVICE ALARMED AFTER SHE RECEIVED 3.4 UNITS OF INSULIN. CUSTOMER'S BLOOD GLUCOSE IS 422 MG/DL. SHE STATED SHE IS HIGH BECAUSE SHE JUST ATE DINNER AND SHE IS ON MEDICATION FOR A NON DIABETES CONDITION. SHE TREATED WITH A MANUAL INJECTION. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER USES THE SENSOR FEATURE. CUSTOMER WAS ADVISED THAT A FALSE MOTOR ERROR MAY BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH DURING BOLUS. CUSTOMER IS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. CUSTOMER STATED SHE WAS IN THE HOSPITAL FOR THREE WEEKS FOR A NON DIABETES RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612069 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention