Model Number 186-0106 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/05/2019 |
Event Type
malfunction
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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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Event Description
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According to the reporter, the device's sensor had an erratic reading then suddenly, no data showed.The value was not inaccurate but the readings disappeared and was unstable.It was replaced with a new sensor to continue treatment.There was no patient outcome.
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Manufacturer Narrative
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Evaluation summary: one sample of device was received for evaluation.The sensor passed inspection with no faults found.The sensor was tested with a sensor lot code tester; the sensor was within expiration date and displayed a ¿sensor valid¿ message.The sensor was scrapped.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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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Event Description
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According to the reporter, prior to use, the device's sensor had an erratic reading then suddenly, no data showed.It was reported that the value was not inaccurate but the readings disappeared and was unstable.Customer reported that it was replaced with a new sensor to continue treatment.There was no patient involvement.
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Search Alerts/Recalls
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