MAUDE Adverse Event Report: MEDTRONIC MINIMED RPL MMT-7811W3 XMTR GST3C LOCKOUT 2.2A; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7811W3

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885); Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

Patient Problem Hypoglycemia (1912)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Information received by medtronic indicated that the charger was blinking solid green.Customer stated that the transmitter was malfunctioned.No harm requiring medical intervention was reported.Troubleshooting was not performed, the customer will continue the use of device.

Manufacturer Narrative

No physical damage to connector pins, cow catcher or case was noted per visual inspection.No traces of moisture / contamination were noted at connector per visual inspection.Unit was able to charge up to two hours.After removing device from charger, the green led flashed properly.After the test plug was installed, the led flashed properly.Unit was able to communicate and sync properly during rf association.No rf communication anomalies noted.Unit passed functional tests including rf and accuracy test.Unable to confirm allegation of low bgs.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.

Manufacturer Narrative

(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.

Event Description

It was reported that the transmitter was return for analysis.The customer had loss of communication between transmitter and insulin pump, and insulin alarm history showed lost sensor signal, sensor signal not found, cannot find sensor signal alarm.

• Brand Name: RPL MMT-7811W3 XMTR GST3C LOCKOUT 2.2A
• 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 Key: 13645820
• MDR Text Key: 287795820
• Report Number: 2032227-2022-119627
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 000000763000400668
• UDI-Public: (01)000000763000400668
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7811W3
• Device Catalogue Number: MMT-7811W3
• Device Lot Number: A000846832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 08/10/2022; 12/12/2022
• Supplement Dates FDA Received: 09/08/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1