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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 09/29/2021 |
Event Type
malfunction
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Event Description
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Medtronic received information that during use of use of an act plus instrument, the customer reported a wrong measurement.The customer stated that the instrument only measured in one cell and sometimes there was a big deference between the readings for the channels.Instrument was replaced with a back up and there was no adverse patient effect.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis: the reported wrong measurement issue was not verified during service.The service technician could not verify the issue.The lift drive assembly, reagent motor and the pcb assy interface cont will be replaced as a precaution.Preventive maintenance and post-repair testing will be performed per specifications.Conclusion: complaint is not confirmed for the act plus instrument¿s reported wrong measurement issue.The issue was not verified during service when the technician could not verify the issue.No patient/clinical safety issues were reported.Trends for issues with this product are monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided 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.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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis update: additional information was received stating that upon further analysis the service technician concluded that the lift drive assembly, reagent motor and the pcb assy interface cont did not need to be replaced as a precaution.During the additional analysis the service technician noted that the reagent drive slider block and the lift-wire were dirty and the lift-wire was out of calibration.The issues were resolved by cleaning the reagent drive slider block and lift-wire and adjusting the height of the lift-wire.Preventive maintenance was performed per specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided 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.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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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