MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX CT/GC/TV; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Model Number	442970
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd max¿ ct/gc/tv false positive results were obtained by the laboratory personnel.The patient was sent to hospital and a new ct/gc pcr was done.The following information was provided by the initial reporter: "would like to know if the meningococcal meningitidis tests can give a false positive on (b)(6)?".
Additional Manufacturer Narrative
H6: investigation summary: the complaint investigation for discrepant results when using the bd max ct/gc/tv (ref (b)(4)) lot 1074292 was performed by the review of manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max ct/gc/tv indicated that lot 1074292 was manufactured according to specifications and met performance requirements.Customer complained about one discrepant sample.A n.Gonorrhoeae (gc) positive result was obtained twice with the bd max¿ ctgctv assay, but another test gave a negative result.Customer provided two run files (runs 2492 and 2500) for investigation.Manual pcr curve adjudication was performed and showed true but low amplification of the gc target in both runs, without anomaly, indicative of true positive results.Low positive samples can occur due to low bacterial load in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Moreover, limit of detection can vary between different assays.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.The customer is also concerned about the specificity of the test and would like to know if meningococcal meningitidis can give a false positive result for neisseria gonorrhoeae (gc target).Review of internal data and package insert (p0185) revealed that cross reactivity tests were performed on samples containing phylogenetically related species and other organisms likely to be found in urogenital specimens.Among them, 62 neisseria strains were tested, including 14 n.Meningitidis strains, and all gave a negative result.Based on these results, cross-reactivity is unlikely.Bd was unable to confirm the exact cause of the customer¿s positive results but there is no reason to believe that the positive result was the result of non-specificity.Overall, no product issue is suspected.There is no indication of an increase in complaints for discrepant results for the bd max ct/gc/tv lot 1074292.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd quality will continue to monitor for trends.H3 other text: see h10.
Event or Problem Description
It was reported that while using bd max¿ ct/gc/tv false positive results were obtained by the laboratory personnel.The patient was sent to hospital and a new ct/gc pcr was done.The following information was provided by the initial reporter: "would like to know if the meningococcal meningitidis tests can give a false positive on neisseria gonorrhoeae?".

• Brand Name: BD MAX CT/GC/TV
• Common Device Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 12193962
• Report Number: 3007420875-2021-00038
• Device Sequence Number: 1494354
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 00382904429706
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/01/2022
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 1074292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR