BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 8830357 · Received July 26, 2019

    Report

    Report Number
    2032227-2019-36873
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    May 1, 2019
    Report Date
    March 9, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONING PROPERLY. NO BUTTON ERROR ALARM DURING TESTING. NO MOISTURE OR CORRODED KEYPAD FOUND. NO FLATTED KEYPAD. CONNECTOR WAS INSPECTED AND LOCKED ON LCD BOARD. DEVICE PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST, NO ANOMALY NOTED DURING TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA AND KEYPAD ANOMALY. CUSTOMER EXPERIENCED MULTIPLE BLOOD GLUCOSE VALUE SUCH AS 48 MG/DL, 54 MG/DL, 58 MG/DL AND 60 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS TREATED WITH ALMOND ILK AND PEANUT BUTTER. CUSTOMER STATED THAT THE BUTTONS ON THE INSULIN PUMP ARE STARTING TO STICK AND UNEXPECTEDLY GOES LOW. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625730 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAS A6751LNASJ 00763000161170

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other FRN-MMT-332-RSVR, UNOMED INF SET