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A customer in (b)(6) notified biomérieux of experiencing an issue where the customer's bact/alert® virtuo® a unit (ref 411660, serial (b)(4)) software locked up and after rebooting several errors were displayed, leading to bottles being unloaded and subcultured.The customer communicated that 300 bottles were affected by the instrument issue.The customer unloaded all of the loaded bottles and visually inspected the sensors on each bottle.Suspicious bottles were subcultured and gram staining was performed.The customer did not provide details regarding the bottle ids or how many bottles were positive for growth.Additionally, the customer stated that the virtuo did not provide final results for 30 bottles.The customer reported these bottles as negative to the physician after the maximum test time.The customer then verified these 30 bottles and checked for growth.The customer obtained growth on six (6) of the bottles and corrected the results sent to the physician.Due to the additional subculturing and verification of growth, the customer experienced a delay of >24 hours in reporting results.However, there is no indication or report from the laboratory that the delay in reporting the results led to any adverse event related to any patient's state of health.The actual number of patients impacted by the delay was not provided by the customer.A biomérieux internal investigation has been initiated.
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This report was initially submitted following notification from a customer in germany regarding an issue where the customer's bact/alert® virtuo® a unit (ref 411660, serial (b)(6)) software halted and after rebooting several errors were displayed, leading to bottles being unloaded and subcultured.A biomérieux internal investigation has been completed with the following results: log files were reviewed for the lock-up and errors 45 and 47 (software data validation error and subculture recommended respectively).Log files recorded a power up event that occurred on (b)(6) 2020 06:39 (turned off then on, the main ac power switch).Server log showed that the master control board (mcb) rebooted as expected.After the reboot, the log files had load dates for 30 bottles that were significantly earlier (months earlier) than the actual load date.This caused the error 45 software data validation error and subculture event.This was to be expected since the system is designed to notify users with a recommended subculture message when large time errors are detected.The dlog.Log and archive_dlog.Log generated by the mcb contained ¿computation error 6 in growth¿¿ with no other messages in either the dlog.Log or archive_dlog.Log.The date codes were from february 2019 which indicated that the mcb time-keeping was in error.The instrument logs indicated 55 bottles were ejected as a result of errors 45 and 47 and determined negative-to-date.It is important to note that a ¿subculture recommended¿ error was logged by the system, reported by the customer, and recorded in this complaint.Previously the complaint mentioned the instrument automatically reported negative to the physician.However, the log files determined the instrument issued messages recommending subculture with a negative to date result.In addition, the customer mentioned the system had stopped taking readings on the remaining 221 bottles under test in the incubator; however, this statement was never confirmed.The log files made available indicated readings were performed on the bottles remaining in the system.No errors were generated or logged which indicated a failure of the system to perform readings.No additional information was provided to support the customer claim of the instrument not performing bottle readings on the remaining 221 bottles under test.The specifics of this case were consistent with a faulty mcb battery.¿ instrument was powered down.¿ when mcb re-booted, the time was significantly incorrect (off by approximately 18 months).¿ errors 45 and 47 were presented to the user.¿ computation error 6 in growth¿ contained in the dlog.Log.¿ bottles were ejected.¿ data validation error (45) reported for each bottle loaded in the instrument that had the corrupted time stamp.The mcb battery was not submitted to be investigated.The most likely root cause is a bad mcb battery because when the battery is faulty and the ac power source is removed then the correct time record is lost.Then when the ac power returns, the mcb communicates with the pc but now the time stamps are incorrect.This then causes the bottle time stamps to be off and triggers errors 45 and 47.The system computer algorithm is not able to process the bottles because of the incorrect date and time codes so a computation error 6 is triggered in growth messages for every bottle.The battery voltage is not monitored and a bad mcb battery cannot be detected by the instrument.A field service engineer (fse) replaced the battery as a corrective action and updated the customer's instrument to release 3.The customer has not noted any additional issues.This instrument was installed in march 2018 and was not due for a battery replacement.The cause of the trigger for this issue (virtuo® locked up after attempt to unload a positive bottle) could not be determined.If the mcb battery had been operating properly, it¿s likely that the virtuo® would have recovered from the original trigger either automatically or with user intervention.
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