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| Model Number 411660 |
| Device Problem
Failure to Obtain Sample (2533)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Issue description: a customer in (b)(6) notified biomérieux of experiencing an issue in which a positive bact/alert® bottle (reference not provided) was reported to be lost in their virtuo® a unit (ref.411660, serial (b)(4)).Delayed result (>8 hours) was obtained for one ¿missing bottle¿.The customer stated that they had an issue regarding a "missing bottle".Biomérieux¿s fse (field system engineer) visited the customer site and identified that they had a connection issue due to the firewall and also a robot jam during calibration.The firewall and connection issues were resolved, but bottles had gotten stuck in racks so the racks had to be disabled.The fse resolved the issue with the racks so the instrument could be fully used again with all racks enabled.The issue with the "missing bottle" caused a delay in reporting result of a positive bottle.It was reported that there was blood culture result delayed more than 8 hours to the physician.The customer also reported that the users of the instruments may have been exposed to blood due to broken bottles.It was reported that four (4) bottles were analyzed.The three (3) that were not broken gave a negative result.In the end the bottle was found in the correct cell (m7), and was broken in the bottom.The customer stated that the bottle could not be found in m7 while it was missing.Biomérieux will initiate an internal investigation.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.An investigation has been initiated.
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Manufacturer Narrative
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Context: a customer in sweden notified biomérieux of experiencing an issue in which a positive bact/alert® bottle (reference not provided) was reported to be lost in their virtuo® a unit (ref.411660, serial (b)(6)).Delayed result (>8 hours) was obtained for one ¿missing bottle¿.An investigation was initiated in response to one complaint relating to a positive bact/alert® fn plus bottle id nrzshywz that did not unload from virtuo® when the button was pressed per the customer, and coinciding with a communication failure between vilink® viewer and myla®.The customer said the positive flag on the instrument disappeared after the button was pressed.The system is part number 411660 bact/alert® virtuo® a unit serial number (b)(6) version r3 in a primary/secondary configuration with myla® server.The bottle flagged positive, but the customer had difficulty finding the bottle, and did eventually locate this bottle in cell 1-m7 and unload it.No specific harm to this patient was described by the customer, but it was claimed there was a delay of more than 8 hours of the positive result to the physician that then led to a delay in treatment for the patient.Investigation: there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue with no implication of a trend.The immediate action by the customer is not clear (but it was stated they could not find the bottle).The bottle flagged positive and was removed from the instrument from its original loading cell position.Biomérieux was contacted and the immediate action by local customer service (lcs) was to correct a communication alarm and gather details about other alarms.A ¿missing bottle¿ was found loaded and to be broken and leaking.Opening the door some racks were bloody, and some bottles are stuck due to dried blood.Two racks were contaminated and disabled, to be cleaned.The local fse (field service engineer) was dispatched to the site.Lcs escalated the case to global customer service (gcs) for assistance to review the instrument logs and alarms, and to understand why the customer did not find the bottle.The logs show the instrument did alarm with error 83 immediately indicating the bottle was stuck in the cell.The alarm was acknowledged and dismissed by the customer.The error message gives adequate directions to the user on the steps to take to resolve the issue and unload the bottle.The positive bottle instrument result was not delayed, as it was sent to the lis appropriately.The instrument log files, data backup were reviewed by the investigator.The virtuo notified myla of the positive result at the time the result was determined.Myla notified the lis of the positive result at the time the result was determined.After the bottle result was determined positive, the user attempted three times to request to unload all positive bottles on blod2ks.Each time the user requested to unload the positive bottle, alarm 83 displayed ¿bottle unable to be removed from cell.Open the instrument door, remove the bottle from the listed cell, close the door and place the bottle on the conveyor.[83] instrument name: blod2ks, rack: m, cell: 7¿.The three attempts occurred over the course of 8 hours.On the third attempt, the user followed the on screen instructions to resolve the issue by opening the door and manually removing the bottle from the cell.The virtuo instrument is functioning as designed.The root cause for the lost bottle was determined to be operator error in not resolving the alarm promptly by opening the door and locating the bottle.The bottle was stuck in the cell because it was broken and blood had leaked and dried making it stick, such that the robot could not pull it out.The user did not appropriately resolve alarm 83 the first time it appeared.This caused the customer to believe the bottle was missing even though the bottle remained in the instrument.This resulted in a delay of the positive bottle being removed from the virtuo instrument in order to allow this bottle to follow the lab¿s normal process for handling positive blood culture bottles.The positive result was transmitted from virtuo to myla to the lis at the time bottle was first determined positive.The recommended corrective action is retraining of the customer on how to appropriately resolve instrument alarms.There is potential impact to the patient because the blood culture bottle involved was not unloaded promptly by the user, and the gram stain and subculture results were delayed in being reported to the physician.The gram stain and subculture were positive for a staphylococci.There was a mate aerobic bottle that was negative.Other blood culture sets were negative for this patient.The instrument positive result had no delay in being reported to the lis from virtuo.The impact to the customer is that a delayed positive gram stain result could harm a patient, as the physician may not have the information needed for the proper treatment.The impact to business is that a patient could potentially be harmed if a positive gram stain result is delayed, thus resulting in serious injury or death.A broken bottle that leaked in the cell caused the bottle to be stuck and the instrument alarmed appropriately with error 83.Conclusion: the investigation has assessed this issue to be related to operator error.The risk assessment performed by biomérieux determined the final risk to patient to be low.The investigator reviewed the user_manual_-_050574-01_-_en_-_2019-08_-_bactalert_virtuo_system_r3.0 and concluded the user manual contains adequate directions and tools (reports) for the user to view and locate bottle records and results.Queries of the manufacturing data do not reveal any adverse trend for the issue.The investigator did not find any adverse trend in the complaint data where a bottle was lost related to the error 83 instrument alarm message.There were no similar complaints.Global customer service (gcs) reminds local customer service (lcs) and the customer that the instrument reports can be viewed and printed for any bottle records on the system to assist with locating bottles.The investigation recommends the user be retrained by the lcs or fas (field application specialist) on responding to instrument alarms and opening the door of the instrument to manually locate a bottle in the rack and to unload the bottle.Always press the button to expand and view alarm details when the button is present on the alarm.The investigator noted the system is being used in english, and is not translated to their native language.Gcs also reminds customer to follow the instructions for use (ifu) to inspect bottles before use and before loading on the instrument.Any bottles found with damage (e.G.Cracks on bottom, or seepage of sample under sensor) should not be used or loaded on the instrument.If hospital staff who are transporting inoculated blood culture bottles to the laboratory have dropped a bottle, they should alert the laboratory upon delivery so the bottle can be carefully inspected for damage.The ifu also states to wear disposable gloves and handle inoculated bottles cautiously as though capable of transmitting infectious agents.Consult a physician immediately if contaminated materials are ingested or come in contact with open lacerations, lesions, or other breaks in skin.No further action required.
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Manufacturer Narrative
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The mdr guidance, "medical device reporting for manufacturers, issued november 8, 2016", section 2.15, establishes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.Biomérieux has performed a review and analysis of the mdr submissions, specific to the biomérieux bact/alert® reagents and virtuo® instrument.The review included mdrs submitted to the fda from (b)(6) 2022 to (b)(6) 2024.Based upon our review and analysis of biomérieux bact/alert® reagents and virtuo® instrument mdr submissions, there have been no customer claims of death or serious injury in the past two (2) years.Each has been investigated or is currently undergoing investigation, and any issues have been addressed by the manufacturing site.With the completion of our mdr data analysis, we have updated our mdr criteria for bact/alert® reagents and virtuo® instrument.Malfunction events for medical device problem code: a090811, unable to obtain readings will no longer be reported for all bact/alert® reagents and virtuo® instrument (product codes: mdb, mzc) as these events are not "likely to cause or contribute to a death or serious injury" if they were to recur.Moving forward, if we become aware of a death or serious injury event related to nonstandard device results obtained with an bact/alert® reagents or virtuo® instrument, we will report that event to the fda per the fda mdr guidance and update our mdr criteria to include reporting the specific associated malfunction as required by the mdr guidance.
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Search Alerts/Recalls
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