BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 13176338 · Received January 6, 2022

    Report

    Report Number
    2032227-2022-101504
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    April 19, 2018
    Report Date
    January 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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

    MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON OCTOBER 11, 2021 REGARDING INSULIN PUMPS ALLEGEDLY SUBJECT TO THE SAFETY NOTIFICATION RELATED TO MISSING OR BROKEN RETAINER RINGS. REPORTER ALLEGES THAT THE USE OF MEDTRONIC INSULIN PUMP CAUSED PERSONAL INJURIES TO THE CUSTOMER ON THE FOLLOWING DATES: 17 NOVEMBER, 2017 TO 24 NOVEMBER, 2017, 19 APRIL, 2018 TO 27 APRIL, 2018, 30 APRIL, 2018, 21 MAY, 2018 TO 22 MAY, 2018, 15 JUNE, 2018 TO 20 JUNE, 2018, 14 JULY, 2020, 11 SEPTEMBER, 2020 TO 15 SEPTEMBER, 2020, 8 OCTOBER, 2020, 27 OCTOBER, 2020 TO 6 NOVEMBER, 2020, 27 NOVEMBER, 2020, 20 JANUARY, 2021, 24 FEBRUARY 2021, 14 APRIL, 2021, 2 JUNE, 2021 TO 6 JUNE, 2021 AND 30 JUNE, 2021 . NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS. REPORTER ALLEGES THAT THE USE OF ONE OR MORE MEDTRONIC MINIMED 600 SERIES INSULIN PUMPS WITH A DAMAGED, MISSING, OR BROKEN RETAINER RING CAUSED THE CLAIMANT TO SUFFER PERSONAL INJURIES. THE ALLEGATION DID NOT SPECIFY THE PUMP IDENTIFIER (NG2134854H) AND THEREFORE ALL 600 SERIES INSULIN PUMPS IN POSSESSION OF THE CLAIMANT, INCLUDING THIS PUMP, ARE CONSIDERED POTENTIALLY WITHIN THE SCOPE OF THE REPORT PENDING CONFIRMATION OF THE AFFECTED SERIAL NUMBER(S). WHEN AND IF THE AFFECTED SERIAL NUMBER IS IDENTIFIED, ALL RELATED REPORTS WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082464 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG40DUV 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female