BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 9501790 · Received December 20, 2019

    Report

    Report Number
    2032227-2019-135821
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 15, 2019
    Report Date
    February 24, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH A SCRATCHED CASE. THE TEST RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. DEVICE PASSED THE SELF TEST AND DISPLACEMENT TEST. NO HAZE/FOG WAS FOUND ON THE LCD SCREEN DURING VISUAL INSPECTION. THE FORMATTED HISTORY FILES SHOWS DUPLICATE BLOOD GLUCOSE VALUE OF 82 MG/DL, FIRST ENTRY RECORDED FROM THE RF-LINKED BLOOD GLUCOSE METER AT (B)(6) 2019 00:27:28 AND SECOND ENTRY RECORDED 82 MG/DL, SENT FOR CALIBRATION PROCESS AT (B)(6) 2019 00:27:32. THE FORMATTED HISTORY FILES DOESN'T SHOW 136 BLOOD GLUCOSE VALUE RECORDED. NO INSULIN PUMP HISTORY ANOMALY NOTED DURING THE 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 THE INSULIN PUMP HAD DAMAGE, SCREEN SHOWS A DAZE AND BRIGHTNESS CAUSING LIGHT FOG. THE CUSTOMER¿S BLOOD GLUCOSE WAS 136 MG/DL, 82 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THEY CAN READ THE SCREEN BUT IT DID NOT RIGHT AND POOR QUALITY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299665 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3WYBU 00763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR