GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC
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Catalog Number 443461 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
malfunction
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Event Description
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Report 3 of 4: it was reported that during use with the bd max¿ mrsa xt, there were false negative results.There was no report of patient impact.Run 195/sample (b)(4) ¿ sample material: swab (eswab) ¿ swab location: nose/throat ¿ testing bd max mrsa-xt: mrsa not detected (mrej negative; meca/mecc positive ct 29.0; ic positive) ¿ fluorotype mrsa testing (hain bruker): mrsa detected (sccmec positive; meca/mecc positive) ¿ mrsa culture: positive (phenotypically mrsa detected) ¿ antibiogram: o oxacillin, ss-lactams and tetracycline resistant o erythromycin, clindamycin, gentamicin, sxt, tigecycline, moxifloxacin, vancomycin, linezolid, daptomycin sensitive o levofloxacin intermediate o resistance phenotype is reminiscent of livestock-associated/la-mrsa strains.
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Manufacturer Narrative
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E1.Initial reporter phone #: (b)(6) e1.Initial reporter fax #: (b)(6) there were multiple pma/510k numbers.The information for each additional pma/510k is as follows: g.5.Pma / 510(k)#: ooi h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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Report 3 of 4: it was reported that during use with the bd max¿ mrsa xt, there were false negative results.There was no report of patient impact.Run 195/sample: (b)(4).Sample material: swab (eswab).Swab location: nose/throat.Testing bd max mrsa-xt: mrsa not detected (mrej negative; meca/mecc positive ct 29.0; ic positive).Fluorotype mrsa testing (hain bruker): mrsa detected (sccmec positive; meca/mecc positive).Mrsa culture: positive (phenotypically mrsa detected).Antibiogram: oxacillin, ss-lactams and tetracycline resistant erythromycin, clindamycin, gentamicin, sxt, tigecycline, moxifloxacin, vancomycin, linezolid, daptomycin sensitive.Levofloxacin intermediate.Resistance phenotype is reminiscent of livestock-associated/la-mrsa strains.
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Manufacturer Narrative
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H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ mrsa xt kit (ref.443461) from lot: 3265828 was performed by the review of manufacturing records, review of customer¿s data, retain material testing and by the complaint¿s history review.Customer complained about discrepant results when using bd max¿ mrsa xt kit from lot: 3265828 versus culture and (b)(6) fluorotype mrsa testing.Review of the manufacturing records of bd max¿ mrsa xt kit indicated that lot: 3265828 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ mrsa xt kit from lot: 3265828 was tested and the results met the specifications.Database of bd max¿ instrument ct3017 was received, for investigation.Runs were analyzed and manual pcr curve adjudication was conducted across the samples identified by the customer (run (b)(4); position a7 and a9, 191; a1, 195; a2 and a3).Analysis revealed that all the affected samples were negative for the mrej target (fam channel) but positive for the meca/c (resistance gene) target (rox channel).No anomaly was observed in the curves and results appear to be true negative results.Based on the culture results reported and (b)(6) testing results, the customer¿s samples appear to be true mrsa strains.As mentioned in the package insert p0205, the bd max¿ mrsa xt assay is designed to detect mrej genotypes i, ii, iii, iv, v, vi, vii, ix, xiii, xiv, and xxi which represent most of meca and mecc harboring mrsa strains (belonging to different sccmec/mrej types) accounting for more than 98% of worldwide strains tested by bd to date.However, it must be noted that sscmec typing and mrej typing are different typing methods, without any link between them.The investigation suggests that the customer strain may have been undetected by the bd max¿ mrsa xt assay.Without analysis of the customer strain, bd was unable to confirm the customer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ mrsa xt assay from lot: 3265828.The root cause was not identified.Bd acknowledge the customer issue but cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard or trends was identified.Bd quality will continue to monitor for trends.
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