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A customer in (b)(6) notified biomérieux of experiencing an issue in which the customer found a dropped bact/alert® bpn bottle in association with their virtuo® a unit (ref 411660, serial (b)(4)).No result was obtained for the dropped bottle.The customer stated that the bottle was found at the bottom of one of their virtuo modules.According to the customer, the bottle was loaded on (b)(6) 2021 and there was a robot jam error that occurred around the time this bottle was loaded.Global customer service (gcs) reviewed the instrument logs.Gcs searched and could not find the bottle in question, (b)(4).Gcs did locate information in the audit trail for the mate bottle, patrdw74.The mate bottle was loaded on (instrument 4) spc bank2-b1 [serial # (b)(4)).The error logs showed no jams or adverse events during the incubation period of the bottle for instrument (b)(4).The instrument in which the mate bottle was loaded did have a jam but not a "dropped bottle" alarm.The instrument constantly monitors the status of where bottles reside in the instrument.In the event a bottle did not make it to its destination there would be an associated dropped bottle alarm.This was not witnessed on either instrument.Gcs has not identified any evidence from the logs that the bottle in question was actually loaded by the instrument, and it is possible that the user dropped the bottle inside the instrument.Additional information has been requested from the customer.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.A biomérieux internal investigation will be initiated.
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An investigation (inv-6330) was conducted in response to one blood bank customer complaint relating to a dropped platelet culture bottle pnvfcx4z after a robot jam on bact/alert® virtuo® serial number vrta-00881 version r2 in a primary/secondary configuration with myla server.An alarm for error (41) robot jammed occurred and was associated with the dropped bottle.The customer reported that they discovered a bpn bottle (pnvfcx4z, a520021896469009) that had fallen inside their instrument.The bottle was loaded on 13jun2021 and discovered on 26jun2021.The customer knows the load date because it was loaded with a mate bottle patrdw74.The customer was not aware that the bottle had dropped until it was discovered on 26jun2021.The immediate action of the customer was to notify biomérieux when the bottle was found in the floor of the instrument.Biomérieux level 1 local customer service requested log files and a backup and escalated the case to level 2 global customer service.The instrument data including a picture, log files, and a virtuo instrument data backup were reviewed by the investigator.The root cause of the bottle being undetected in the bottom of the instrument is that the customer did not visually check the bottom of the instrument after the robot jam per the guidance for the error in the virtuo system user manual.The investigation found the root cause for the delay associated with the dropped bottle occurred because the customer did not open the door long enough to examine the instrument for the presence of the dropped bottle.The directions in the viruto user manual for the error (41) robot jammed do include steps to perform this action, as dropped bottles can occur with a robot jam event.Biomérieux investigator was able to confirm in a lab instrument that a bottle drop caused by a robot jam would present the bottle jam alarm, but not the dropped bottle alarm.The virtuo firmware architect confirmed that a robot jam would not necessarily trigger a bottle dropped alarm.A robot jam alarm message should be followed by an inspection of the instrument for misplaced bottles, including ¿on the floor of the instrument¿¿ that statement is located in virtuo 2.0 virtuo system user manual 514927-1en1 -- [2017-02] page 8-33 under unjamming the robot.There is no impact to the patient because the platelet unit culture involved in the incident under investigation was negative.Pnvfcx4z was the dropped bottle, and the mate bottle patrdw74 tested normally and was final negative.The impact to the customer is that there could be potential for no or delayed test results when the error occurs, and this could lead to a missed positive bottle that would allow a contaminated unit to be transfused to a patient.Not all error (41) robot jammed alarms result in a dropped bottle, but it is possible to occur; therefore the virtuo user manual directs the user to check for a dropped bottle when this error occurs.The customer's impact is mitigated if the user manual instruction is followed.The impact to business is that the error could potentially harm a patient if the user does not follow the user manual directions to check the instrument when the error occurs.If the user does not follow the directions to reload the dropped bottle, the bottle readings will not be taken on the instrument and no result will be provided.If the bottle is found within the test time (normally five to seven days), it can be handled manually by performing a gram stain and subculture as it was incubated inside the instrument.Having a mate bottle that did test normally also reduces the risk that a positive result would be missed or delayed.The risk assessment for the patient/recipient for a hazard of no result has a severity of critical with a p1 (probability of the cause leading to the hazard) assessed as improbable, and final risk of irrelevant.Queries of the manufacturing data, and the complaint data do not reveal any adverse trend for the (41) robot jammed error code.The error does occur frequently as the robot is a moving part that is integral to the loading and unloading functions for bottles.The investigator did not find any adverse trend for other complaints for the (41) robot jammed error code where a dropped bottle was delayed in being addressed by a customer.The bact/alert virtuo user manual was reviewed by the investigator and found to have adequate directions for the user.However, the bact/alert virtuo microbial detection system user manual release 3.0 instruction to inspect the bottom of the instrument after a robot jam will be revised to include additional clarity.Helix issue # 2989 has been entered into virtuo¿s issues database to add conspicuous instructions to visually inspect the bottom of the virtuo instrument for dropped bottle(s) after a robot jam in two places: 1) clearing robot jams section and 2) alert and alarm causes and resolutions table; a robot jam has occurred.Level 1 local customer service has advised the customer to always check thoroughly inside the instrument for misplaced/dropped bottles or calibrators when the error (41) robot jammed alarm occurs.Note the investigator recommended the customer update to the current version for virtuo, which is release 3 in order to be compliant.
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