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Model Number ACT200 |
Device Problems
Electrical /Electronic Property Problem (1198); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information that prior to use of an act plus instrument, it was reported that the reading value was too high.The use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.
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Manufacturer Narrative
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Device evaluation summary: the reported issue that the reading value was too high was verified during service.The issue was resolved by resetting all the electrical connections and cleaning the heater block and sensors.Service technician tested the act plus with act trac and hr act cartridge and instrument was in working good condition.Post repair testing was performed per specifications.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 employee 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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Manufacturer Narrative
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Medtronic received additional information that the left side channel readings were too high.The lot numbers of cartridges and/or controls used are unavailable.Both liquid and electronic (acttrac or heptrac) controls were used.The quality control is performed for this unit every half a year.There was no error codes associated with this report.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 employee 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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Search Alerts/Recalls
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