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A customer in (b)(6) reported that following a delivery of vitek 2 ast-p662 cards, a box of 20 cards (ref 423439 - lot 8221705103 - expiry date: 28/07/2022) was found to have unsealed card pouches.In spite of the discrepant pouches, the customer used the cards to process samples.When used, these cards did not present correct analysis of the antimicrobials.This was verified upon repeating analysis using a fresh batch of cards whose pouches were properly sealed.Specific details regarding the incorrect results were not provided by the customer.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
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An investigation was initiated in response to a customer complaint in which the customer identified a box of 20 vitek® 2 ast-p662 cards (ref (b)(4) - lot 8221705103 - expiry date: 28/07/2022) that had unsealed card pouches.Despite finding the unsealed pouches, the customer used the cards to process samples and these cards did not present correct analysis of the antimicrobials.Investigation complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the pouch issue as a trend.Manufacturing record review: vitek 2 ast-p662 lot 8221705103 was manufactured on 26jan2021.The pouches received for this customer complaint were manufactured on poucher 4.The device history record (dhr) for ast-p662 lot 8221705103 was reviewed.Poucher 4 ran from 0948 to 1452 on 26jan2021.There was a downtime entry at 1237 on poucher 4 for ¿cards jam.¿ this event was completed at 1300 with a corrective action of ¿removed card jam.¿ there were no in-process aql findings for pouch integrity.There were no final qc inspection findings for pouch integrity.Poucher 4 operational data was reviewed.There was no event that shows the sensor was blocked for more than 3 seconds, which would result in the following error message: ¿film detected at top seal.¿ there was a stop event at 14:04:58 for ¿cartoner not available.¿ operation resumed at 14:05:41.There was a second stop event at 14:05:47 for ¿cycle stop.¿ operation resumed at 14:06:02.The corresponding pouch counts for rejects in that time frame increased by 10, an indication there were pouches with issues.The reject count after resuming from the second stop event does not increase for another 4 minutes, also giving an indication that the issue was corrected at the second cycle stop.It is possible that the sensors were only partially blocked during this time.Without a ¿film detected at top seal¿ there is no indication that the sensor was working incorrectly.It is likely that the position of the webbing shifted slightly when operation resumed at 14:05:41 causing the webbing tension to shift as well.This momentary fluctuation in webbing tension can result in the webbing walking out of the secondary and tertiary fin wheels.As stated, there were no aqls found for pouch integrity issues on lot 8221705103.The pouchers eject 1 in 55 pouches to be inspected for aql sampling by operators.The poucher runs at approximately 125 pouches/minute, resulting in an aql pouch being kicked off roughly every 30 seconds.Pouch operators inspect for pouch integrity violations on the front and back of all ejected aql pouches.As no integrity violations were identified during in-process aql sampling, less than 55 pouches were impacted by this issue.If the issue persisted until the next ejected in-process aql pouch, it would have been identified and containment actions would have been performed.Based on the poucher rate of 125 pouches/minute, and the start and stop time of 14:05:41 and 14:05:47 respectively, the actual number of pouches that may have had top seal issues would be no more than 15 pouches.It is likely that the customer received all of the defect pouches and very unlikely there are any more in circulation.Retain sample inspection: engineering inspected retains pertaining to lot 8221705103, a112b.Of the five (5) cartons of retains available, two (2) were from poucher 4 (the rest were from poucher 3).These two cartons from poucher 4 contained 20 cards each.One carton was pouched at 1146 and the other was pouched at 1353.All 40 pouches between the two cartons show proper top seals.Root cause: the cause of the unsealed pouches is the poucher webbing coming out of the fin wheels on the poucher.There are three (3) fin wheels in place to create the top seal on the poucher.If the webbing goes through the first wheel as expected and then becomes dislodged on either of the next two wheels, the top seal will be incomplete as seen in the complaint.There were ribs on the top seal of the pouches in the pictures the customer provided, which indicates the webbing material did pass through at least one, but not all of the top seal wheels.Corrective actions: since the manufacture date of ast-p662 lot 8221705103 (26jan2021), actions have been taken that aim to control/prevent poucher webbing issues from occurring.Waiver (b)(4) was a waiver to procedure 059765 ¿ poucher cartoner maintenance and troubleshooting.Section f of 059765 was updated to direct the operator to put the poucher in first article mode when splicing in new webbing.This will cause all pouches to be rejected until the operator confirms webbing alignment is adequate.This waiver went into effect on 22nov2021 and closed on 10jan2022.While the root cause of the unsealed pouches for ast-p662 lot 8221705103 is not from a webbing change, it is a possible root cause for the same issue.Additionally, procedure 059765 will be updated through change request (b)(4) to provide wording in section a- webbing tension cases that do not have a ¿film detected at top seal¿ to still require operators to inspect pouches on the track at the time of the issue occurring.This will help prevent containment issues going forward.
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