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Model Number ACT200 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Correction/ additional info b5: medtronic received information that during use of a act plus instrument, it was reported that the act test result was abnormal.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that only the client's clinical test results were abnormal and not the liquid or electronic quality controls (qcs).There was no error codes associated with this report.No control values were obtained.Medtronic received additional information that the difference in the test result is too large, so that the test result will not be accepted.The test was performed on a patient and a blood sample.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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Device evaluation summary: the reported issue that the act test result was abnormal was verified during service.Service technician found no scratches but there was an act operation exception during preliminary analysis and a cartridge type sets issue.The issue was resolved by clean reagent channel.Preventative maintenance 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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Event Description
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Medtronic received information that prior to use of an act plus instrument, it was reported that the act test result was abnormal.The use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that only the client's clinical test results were abnormal and not the liquid or electronic quality controls (qcs).There was no error codes associated with this report.No control values were obtained.
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Search Alerts/Recalls
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