A customer in (b)(6) reported to biomérieux an increase in false positive results in association with chromid® (b)(6).Initially, the customer reported the issue involved chromid® (b)(6) smart; however, on (b)(6) 2017, the customer reported the product as chromid® (b)(6) (lot 1005316120).The customer reported the chromid® (b)(6) is mostly used for screening nose and throat cultures, and that detection of a false positive is confirmed by maldi-tof and vitek® 2 ast testing.The customer stated they have recently noticed a decrease in the false positive rate.The customer reported that results were impacted and there has been error in patient treatment along with a delay for reporting results.There is no indication or report from the hospital or treating physician to biomérieux that discrepant results led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.
|
Note: this supplement report is being submitted following fda notification of a missing report.The initial supplement report was inadvertently labeled with an incorrect report number (3002769707-2017-00363), and was therefore not linked appropriately to the initial report.The report number should have been 3002769706-2017-00363.An internal biomérieux investigation was performed.The investigation was initiated because a belgian customer complained of obtaining false positive results for chromid mrsa, reference 43451, lot numbers;1005316120 (expiry 08-feb-2017), 1005201380 (expiry 21-dec-2016), and 1005151480 (expiry 01-dec-2016).The customer reported that the product has been in use in their laboratory since 2011, is stored at 2-8°c in the box until plating and that the testing was for screening nose and throat samples, that they use the following protocol: direct from e-swab or 10¿l from amies liquid, and incubation 24/48hrs.The customer reported that the method used for the detection of false positives was id (maldi tof) ast vt2.On 30nov2017, the same customer reported two (2) other impacted lot numbers: 1005970670 (expiry 05-dec-2017).1005990890 (expiry 13-dec-2017).The investigation consisted of a review of complaints registered for the impacted lot numbers, a file review of the impacted lot numbers and analyses of the retained sample plates for the impacted lot numbers within the expiry date.On 22jan2018, a review of complaints recorded for the five (5) impacted lot numbers indicated that no other complaints were registered apart from the complaint in question.A file review of the impacted lot numbers indicated all of the plates conformed with specifications; neither contamination nor defects in appearance were detected.For all the lot numbers reviewed: the quality control of the weight of the product conformed with specifications for the duration of the manufacturing process.The quality control certificate conformed with specifications for the product's appearance, colour, ph, microbiological activity and microbiological state.The technical laboratory quality controls indicated that the quality controls conformed with microbiological activity specifications.The following controls were tested; staphylococcus aureus atcc 43300 bmr, staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231, enterococcus faecalis atcc 29212, staphylococcus aureus 05-04-605, staphylococcus aureus 05-06-614, enterococcus faecalis atcc 29212, staphylococcus aureus atcc 43300 bmr.Non conformances and deviations were not detected on all lot numbers.Analyses of the retained sample plates indicated the following: quality control strains were tested on one (1) of the impacted lot numbers, 1005990890, and a reference lot number, 1006038200 (exp 04-jan-2018).The following controls were tested: staphylococcus aureus atcc 43300 bmr, staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231, enterococcus faecalis atcc 29212, staphylococcus aureus 05-04-605, staphylococcus aureus 05-06-614, enterococcus faecalis atcc 29212, and staphylococcus aureus atcc 43300 bmr.The test results indicated that the quality controls conformed with microbiological activity specifications for both lots tested.The testing performed did not reproduce the issue observed by the customer.As the patient strains in question were not returned by the customer, further investigations could not be pursued.Conclusion: a review of the complaints for the five (5) impacted lot numbers indicated that no other complaints were registered.The review of the lot number files indicated conformance with specifications.Analyses of the retained sample plates for one (1) of the impacted lot numbers and a reference lot number indicated that the quality controls conformed with microbiological activity specifications.Without the return of the strains in question, it was not possible to investigate this issue any further.Of note, the package insert states in the reading and interpretation section "a.Direct inoculation · after 18-24 hours of incubation, for nose specimens, a green color is characteristic of mrsa.For the other types of specimens the typical colonies must be identified using biochemical or immunological tests (s.Aureus).If identification of s.Aureus is confirmed, check the resistance of the strain to methicillin.· after 48 hours of incubation and whatever the type of specimen, the typical colonies should be identified following the same procedure.".
|