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| Model Number 411660 |
| Device Problem
Failure to Power Up (1476)
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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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Intended use: bact/alert® virtuo¿ microbial detection system is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.Issue description: a blood bank customer in the united states notified biomérieux of a malfunction with the virtuo, a unit (ref (b)(4), serial number (b)(4)) that occurred after a pc replacement and which lead to delayed results greater than one day.The customer reported that :¿pc will not boot.Cycling power to the instrument was unsuccessful¿.A local field service engineer (fse) visited the customer site and replaced the pc.After pc replacement, the existing bottles under test unloaded.The customer reloaded the bottles.As a precaution, the customer was required to subculture the bottles remaining in the incubator.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation will be initiated.
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Manufacturer Narrative
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Context: a blood bank customer in the united states notified biomérieux of a loss of data after replacement of the computer for bact/alert® virtuo® a unit version r3, part number 411660, serial number (b)(6) installed on 02mar2021.The complaint (b)(4) was from an industry blood bank customer bloodworks nw-renton located in the united states with contact date 24nov2022.The standalone a unit¿s computer was replaced at the customer site due to booting issues.After replacement and a data restore, data that should have been present was no longer present.As a consequence, 409 bottles in the system had their test times reset to 7 days.Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review completed for this issue with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results the investigation involved analysis of instrument backups, log files, interview of the field service engineer (fse), and review of the complaint history.Root cause analysis: the instrument software version is virtuo r3.This expert investigation initiated on 13 dec 2022, as the complaint was determined reportable when the customer indicated a result delay of >24 hours.The customer¿s site experienced database purge errors and escalated a separate complaint (b)(4) to gcs level 2 on 10 oct 2022, which closed on 01 dec 2022.A second complaint (b)(4) was made 23 nov 2022 after the customer elected to replace the internal pc with the newer, advantech model on 26 nov 2022 & closed this second complaint on 27 nov 2022.Both complaints were closed with troubleshooting.A third complaint initiated on 24 nov 2022 followed failed attempts to restore the customer¿s database post-pc replacement, resulting in the creation of this expert investigation.Once the part 3 investigation was assigned, 2 data backups - encompassing until 23 nov 2022 at 1015 and from 26 nov 2022 at 1107 - were made available.No instrument logs were provided by level 1 for the period spanning 23 nov 2022 at 1015 and 26 nov 2022 at 1107.This accountability gap limited biomérieux¿s ability to observe instrument events preceding pc replacement and subsequent unloading of bottles, many of which were originally loaded between 23-26 nov 2022.Although biomérieux cannot verify how many more bottles were added before the pc replacement due to the data gap between 23-26 nov 2022, review of the logs confirmed at least 714 unique bottle records were flagged on 26 nov 2022 for having ¿unknown bottle¿ by the newly installed advantech pc & sent for automatic unloading by the firmware.The root cause cannot be determined due to the unaccounted missing logs.However, the probable reason for the 331 unrecovered bottle records¿as well as the (at least) 423 automatic bottle unloads following a pc replacement procedure on 26 nov 2022¿was a failed database restoration attempted by a fse without the most current backup files.This is further validated by multiple software validation [45] error alarms starting at least at 1120 and the notifications of bottles sent to be unloaded by the firmware starting at 1107.The instruments performed as designed.Correctly following service manual section 4.96 ¿internal pc replacement¿ and creating up to date backups/full system images per sections 3.6 ¿creating a data backup¿ or 3.5 ¿creating a full system backup¿ prior to the restoration process will most likely prevent cases like the one prompting this investigation from occurring again.Finally, it is fitting to note that during the virtuo 3.1 prioritization review, and in response to internal helix issue #2894 ¿pc restore improvements¿¿created 10 jan 2020 as a high priority change request¿the r&d firmware team implemented a code update to prevent this exact issue from occurring in systems upgraded to 3.1 firmware.The change, which successfully passed test run #7365 on 01 mar 2022, ensures that any bottles unloaded due to ¿unexpected bottle has been discovered and unloaded by the instrument¿ [97] error have their individual reload_state set at 0, instead of the default reload_state of 5 assigned when the unrecognized bottles are not synched successfully between pc software and mcb firmware.Doing so is intended to preclude bottles from unloading automatically until a correct database restoration is accomplished.Conclude on the product compliance to its specification/performance.This is an isolated occurrence, and while the specific root cause could not be determined due to missing logs, the probable root cause was a failed database restoration attempted by a fse without the most current backup file available.The instruments performed as designed.Following the service manual directions for restoring files and using a current data backup would have prevented this incident.Without a current backup available, the data restore should not be attempted.
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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 01-jan-2022 to 22-feb-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: a070803, failure to power up 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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