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Model Number 30514 |
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 06/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported issue of the instrument not passing quality controls (qcs) was not verified during service.The service technician was unable to find a problem with the instrument.The service technician had the user run qc¿s while on-site and the instrument passed qc¿s.Preventive maintenance was performed as per specification.Note: the instrument was analyzed in the facility by a medtronic field service technician.The instrument did not return to a medtronic facility for analysis.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.
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Event Description
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Medtronic received information that prior to use of a hms plus instrument, it was reported that the instrument was not passing quality controls (qc's).The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the lot numbers of the control and cartridges used are: 1.Red cartridge (226461816) / control (226042690) 2.White cartridge (226321918) / control (225948208) 3.Abnormal cartridge (226291940) / control (225791323) 4.Normal cartridge (226291940) / control (224962677) 5.Gold cartridge (226406689) / control (226193123) liquid and electronic controls were used.Electronic qc is always run first prior to liquid.Qcs are done to validate new lot numbers for controls or cartridge and otherwise occurs every 30 days.When a repair is done, this requires 5 days of liquid qcs (3 days consecutive must be duplicate liquid qcs) per the customer's policy.No error codes were associated with this event, just failed qc (motor stall, wrong channel, out of range).The instrument was not used for a case until it passes 5 days of liquid controls.
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Search Alerts/Recalls
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