Model Number 10300 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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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An industry customer in (b)(6) notified biomérieux of obtaining a misidentification result in association with the api® listeria 10 strips +10media (ref.10300, lot 1008988000).The customer stated lot 1008988000 did not identify the industry strain.The isolate was also tested on the vitek® 2 which identified the strain as listeria monocytogenes.Biomérieux customer service reviewed the provided lab reports and observed non-reactive/low reactivity on the sugar wells.The customer then tested the atcc® l.Monocytogenes isolate with lots 1008988000, 1008506770, and 1008452670 incubated in two separate incubators at 35°c and 37°c.The same "no identification" results were obtained.Refer to 9615754-2021-00301 and 9615754-2022-00005 for lots 1008452670 and 1008506770, respectively.As there is no patient associated with these industry and quality control strains, there is no adverse impact to any patient¿s state of health.Biomérieux has initiated an internal investigation.
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Manufacturer Narrative
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An industry customer in singapore notified biomérieux of obtaining misidentification results in association with the api® listeria test (ref.(b)(4), lot 1008988000).Review of the batch records for api listeria (ref.(b)(4); lot# 1008452670, 1008988000 and 1008506770), did not highlight any anomalies during manufacturing or quality control which could lead to an identification issue.There is neither trend of complaints on the batches 1008452670, 1008988000 and 1008506770, nor on product reference (b)(4) regarding the issue reported.The quality control strains tested (listeria monocytogenes atcc® 19115¿ and atcc® 7644¿) on the retained sample of the batch impacted (batch 1008988000) complied with specifications.The customer confirmed (07th january 2022) that this issue was not reproduced during retesting at their laboratory with the atcc® 7644¿ strain, using batch 1008988000.The biomérieux complaint investigation laboratory was also unable to determine or confirm a root cause for this customer¿s issue.Biomérieux customer service reminded the customer of the lab protocol for misidentification or no identification issues with api listeria and/or difficulties to interpret: - check the purity of the strains tested before carrying out any identification with api listeria strips, - perform the tests with fresh strains (24 hours), - follow strictly the protocol described on the instruction for use, - respect the validated delay of storage of reagents after opening, - follow the recommendations in the iso 11133 standard regarding the conservation, preparation and subculture of collection strains (such as atcc strains).
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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 api reagents.The review included mdrs submitted to the fda from 01-jan-2022 to 22-feb-2024.Based upon our review and analysis of biomérieux api reagent mdr submissions, there have been no customer claims of death or serious injury within 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 api reagents.Malfunction events for medical device problem code: a0908 - incorrect, inadequate or imprecise result or readings will no longer be reported for all api reagents (product codes: jsc, jsh, jsp, jss, jsw, jto, jwx, jxb, ptj) 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 incorrect, inadequate or imprecise result or readings obtained with an api reagent, 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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