BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13116541 · Received December 30, 2021

    Report

    Report Number
    2032227-2021-236864
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 26, 2021
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. DATE OF EVENT INFORMATION HAS BEEN UPDATED WITH THIS REPORT IN SECTION B3 AND INFORMATION RELATED TO THE EVENT HAS BEEN UPDATED WITH THIS REPORT IN SECTION B5.

    Additional Manufacturer Narrative · 0

    (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 · 0

    CUSTOMER HAD A HIGH BLOOD GLUCOSE OF 280 MG/DL AT TIME OF THE CALL, NO MEDICAL INTERVENTION WAS REQUIRED. AUTOMODE WAS ON WHEN THEY HAD THE HIGH BLOOD GLUCOSE AT TIME OF THE CALL. USER DID NOT STATE IF AUTO MODE FEATURE WAS IN USE OF LOW BLOOD GLUCOSE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT EMERGENCY MEDICAL SERVICES WERE DISPATCHED FOR LOW BLOOD GLUCOSE ON (B)(6), 2021. THE BLOOD GLUCOSE READINGS WERE 103 MG/DL DURING THE INCIDENT. THE CUSTOMER STATED THE BLOOD GLUCOSE HIT REALLY LOW AND THEY ALMOST PASSED OUT. THE CUSTOMER REPORTED SWEATING, DIZZY AND PASSING OUT ALONG WITH LOW READINGS. THE TREATMENT FOR LOW BLOOD GLUCOSE WAS NOT REPORTED. TROUBLESHOOTING FOR THE CUSTOMER¿S LOW BLOOD READINGS WERE DONE. THE CUSTOMER WAS USING AUTO MODE AT THE TIME OF INCIDENT. THE CUSTOMER¿S LAST BLOOD GLUCOSE READING WAS 260 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020250 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5UTLD 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Hospitalization FRN-UNK-RSVR, UNOMED SET.