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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd max¿ ct/gc/tv (b)(6) results were obtained by the laboratory personnel.The sample was sent to a hospital to confirm the results as (b)(6).The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "the client reports a sample (test no.(b)(6)) with suspected (b)(6) which the bd max returned as (b)(6).".
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.
Additional Manufacturer Narrative
H6: investigation: the complaint investigation for discrepant results when using the bd max ct/gc/tv (ref.(b)(4)) lot 1089912 was performed by the review of manufacturing records, retain material testing and verification of complaints history.Review of the manufacturing records of the bd max ct/gc/tv indicated that lot 1089912 was manufactured according to specifications and met performance requirements.The retain material of bd max ct/gc/tv from lot 1089912 was tested in positive and all the reactions gave a positive result, as expected without any anomaly.Customer reported a sample that gave a negative result with the bd max ctgctv assay kit lot 1089912 but the sample was reported as gc positive by the hospital.Moreover, a strong amplification was observed in the 530/565 channel (gc target).The customer would like to know why the bd max did not give a positive result for this sample.Run #1209 was received for investigation and manual pcr curve adjudication was performed.The run contained 4 samples tested with the bd max ctgctv kit lot 1089912 and all the samples gave a negative result.However, analysis of the pcr curves for sample tested in position b6, shows an early and true amplification of the gc target (ct value below 15).Verification of the clinical trial shows that no false negative result was obtained due to early ct value.As mentioned in the assay package insert p0185, the bd max ctgctv assay is designed to be used with female endocervical swab specimens, vaginal swab specimens and male and female urine specimens.Discussion with the customer confirmed that they tested 2 colonies of a pure culture (patient suspected of having gonorrhea conjunctivitis) diluted directly in the sbt which is not the recommended specimen collection method nor the intended use of the assay.The customer sample was thus too concentrated which explains why the customer obtained a false negative result despite true amplification curve.Indeed, results outside of valid thresholds are not considered by the bd max ctgctv algorithm.Based on the available information, no reagents issue is suspected.The root cause of the issue was identified as an off-label use of the assay.There is no indication of an increase in complaints for discrepant results for the bd max ct/gc/tv lot 1089912.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.
Event or Problem Description
It was reported that while using bd max¿ ct/gc/tv false negative results were obtained by the laboratory personnel.The sample was sent to a hospital to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "the client reports a sample (test no.(b)(6)) with suspected positive neisseria gonorrhoeae (gc+) which the bd max returned as negative.".

• 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
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12698821
• Report Number: 3007420875-2021-00059
• Device Sequence Number: 19199325
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/22/2022
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 1089912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown