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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER MMT-7841ZW GST5G OUS; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE

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MEDTRONIC MINIMED TRANSMITTER MMT-7841ZW GST5G OUS; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE Back to Search Results
Model Number MMT-7841ZW
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/29/2025
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed inside the united states.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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event or Problem Description
It was reported to medtronic minimed that the customer experienced lost sensor alarm.The customer reported no adverse event.The event involved product(s) mmt-7841zw.Troubleshooting was not performed.No harm requiring medical intervention was reported.No product return is required for mmt-7841zw.
 
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Brand Name
TRANSMITTER MMT-7841ZW GST5G OUS
Common Device Name
SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
lusine boyadzhyan
18000 devonshire st.
northridge, CA 91325
MDR Report Key23625528
Report Number2032227-2025-304982
Device Sequence Number19076592
Product Code PQF
Combination Product (Y/N)N
Initial Reporter CountrySI
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/22/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMMT-7841ZW
Device Catalogue NumberMMT-7841ZW
Device Lot Number9276
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2025
Initial Report FDA Received Date11/22/2025
Date Device Manufactured07/17/2025
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device A
Patient Sequence Number1
Patient SexUnknown
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