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Product intended use : chromid¿ s.Aureus elite agar is a chromogenic medium for the selective isolation and the direct identification of s.Aureus in human specimens this medium is intended for the prevention and diagnosis of s.Aureus infections using samples of human origin.Description of the issue: on (b)(6) 2020, a customer from (b)(6) notified biomérieux of obtaining atypical color colony growth when testing staphylococcus aureus patient strains with chromid® s.Aureus elite 20 pl (ref.419042; lot 1008162330).The customer reported that he observed white or yellow colonies when testing three specimens from skin abscesses for three different patients.The customer used mass spectrometry to identify the organism and obtained a staphylococcus aureus result for all three patients.According to the product instructions for use, s.Aureus colonies are expected to be pink to light pink; not white or yellow.The customer reported that no incorrect results were reported.There is no indication from the customer that this event led to a delay of result or impacted the patient state of health.This mdr is for patient two.A biomérieux internal investigation has been initiated.
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A customer in france notified biomérieux of obtaining atypical color colony growth when testing specimens from skin abscesses on chromid s.Aureus elite (saide) 20 pl (ref# 419042; lot# 1008162330).The customer used mass spectrometry to confirm the organism identification as staphylococcus aureus.According to the product instructions for use, s.Aureus colonies are expected to be a pink to light pink color; color was white or yellow in this case.The user facility sent in samples of the impacted strains for the internal biomérieux investigation.They also provided pictures of the plates, and stated that the plates were stored at 2/8°c and were not exposed to light.Investigation: the investigator first reviewed the production records for the reported lot.Lot number 1008162330, reference 419042, was manufactured on the 01-july-2020.840 kits of 20 plates were released with an expiry date of 18-oct-2020.In process quality controls results conformed with specifications.In order to release the product, technical laboratory quality controls were performed on retained samples.The samples were tested for ph.All the controls conformed with specifications; non-conformance was not detected on this lot number.Biomérieux retains samples of every lot number released to the market.The retained sample for the impacted lot was tested in parallel with one internal lot number used as reference (lot 1008335390, expiry date on 25-jan-2021).The tests were performed using the quality control (qc) strains staphylococcus aureus atcc 25923, staphylococcus aureus atcc 6538 and staphylococcus aureus atcc 43300.Results were observed after 18-20 hours of incubation at 33-37°c.The three qc strains showed characteristic pink color of staphylococcus aureus on the impacted lot number and the reference lot.Results obtained conformed with specification and were equivalent between both lots tested.The lot number of saide agar (1008162330) was expired at the time the customer samples were received.Consequently, the investigator tested the customer strains on two other lots of saide agar in order to analyze if the issue you observed was linked to a particularity in the enzymatic profile of the strains.They used a newly manufactured lot number (1008378600 - expiry date 16-feb-2021) and another lot at 8 weeks since its manufacturing (1008273230 - expiry date 22-dec-2020).After 18-20 hours of incubation at 33-37°c the strains grew with typical pink color characteristic of staphylococcus aureus, and was observed on all lots tested.The investigator confirmed the identification of the strains vitek® 2 gp identification card, and they obtained an identification s.Aureus with 99 % of confidence.Lastly, the investigator reviewed the complaint records database.No other complaint have been registered against this lot number of saide agar plate.Conclusion: the lot number record analysis indicated that the impacted lot 1008162330 complied with our specifications and neither non-conformances nor deviations were recorded.In addition, are no other complaints registered on this lot number for performance issues.Results obtained during our investigation did not confirm the color issue reported with the three atcc strains of staphylococcus aureus tested.Unfortunately, the three patient strains received for investigation could not be tested on the impacted lot number as it had already expired (18-oct-2020).The testing carried out on two other lots of saide agar showed typical pink colonies for the patient strains of s.Aureus.Of note, this product contains a chromogenic substrate which is sensitive to light, and therefore plates should not be exposed to light except during the inoculation and reading steps.Several recommendation are given in the package insert to ensure the quality of the product until expiry date: ¿do not expose the medium to light¿ ; ¿plates can be stored for 2 weeks (outside their box) at +2°c/+8°c in the cellophane sachet in the dark.¿ ; ¿allow plates to come to room temperature in the dark¿ ; and, ¿immediately incubate the inverted plates in the dark¿.In conclusion, the investigation did not identify a product performance issue.
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