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Model Number UNK_TRANSMITTER |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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.Select patient information cannot be provided due to regional privacy regulations.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.
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Event Description
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Information received by medtronic indicated that the customer reported that the transmitter was unable to pair with the customer's pump.Troubleshooting was performed and the issue was not resolved, customer received lost sensor alert.The customer stated that transmitter blinked when connected to the tester, but not when connected to the sensor.No harm requiring medical intervention was reported.It¿s unknown whether the customer will continue the use of the transmitter.The transmitter will not be returned for analysis.
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Search Alerts/Recalls
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