BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAB

    MDR report key: 7725391 · Received July 27, 2018

    Report

    Report Number
    3004209178-2018-96284
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    June 24, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST. NO EXCESSIVE NO DELIVERY ALARMS NOTED. DRIVE SUPPORT CAP WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INFORMATION PROVIDED IN THE SECTION OF CONCOMITANT PRODUCT WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT. (B)(4).

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP HAD NO DELIVERY ALARM. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 412 MG/DL AND CURRENT BLOOD GLUCOSE WAS 151, 306 MG/DL. THE CUSTOMER TREATED WITH THE MANUAL INJECTION AND INSULIN PUMP. THE CUSTOMER EXPERIENCED THE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE SUCH AS EXCESSIVE THIRST; IRRITABILITY. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY AND ALSO FOR NO DELIVERY ALARM. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT THEY HAD PERFORMED THE HIGH PRESSURE TEST AND THE TEST WAS PASSED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570771 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB A4751NABJ 00643169503670

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other