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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7821LNA GST4C REPLACEMENT; SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED XMTR MMT-7821LNA GST4C REPLACEMENT; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7821LNA
Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885); Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2020
Event Type  malfunction  
Event Description
Medtronic received information that device unable to charge, no communication (unresolved), led anomaly occurred.There was no adverse impact or consequence reported as a result of this event.
 
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter.Unit received with moisture damage /corrosion at connector pins.Unable perform functional test, verify battery or led anomaly due to contamination at the connector pins.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.
 
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Brand Name
XMTR MMT-7821LNA GST4C REPLACEMENT
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key13742615
MDR Text Key297153335
Report Number2032227-2022-129496
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2022
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
Device Operator Lay User/Patient
Device Model NumberMMT-7821LNA
Device Catalogue NumberMMT-7821LNA
Device Lot NumberA000786010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Initial Date Manufacturer Received 05/10/2021
Initial Date FDA Received03/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age61 YR
Patient Weight223
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