MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; NOT CLASSIFIED

Catalog Number 256088

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Eua# (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with bd veritor ¿ sars-cov-2 & flu a+b non reproduceable results were obtained.The first was positive for sars, second one was negative for all.A second bd antigen test was run.This was negative.Pcr testing was not performed.There was no patient impact.Eua# (b)(4).The following information was provided by the initial reporter: it was reported that false positive result.The first cartridge was re-run immediately after the first positive result shown on the analyzer.The positive for flu came up, then the analyzer was turn off and on and the cartridge was re-inserted again, and gave negative results.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges a false positive result for flu a when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch number 1266197.Bd quality performs a systematic approach to investigate false positive result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.Testing for false positive was conducted on the identified lot and the results were correct and accurate.It was reported that the customer observed a line in flu a mark and was concerned about the veritor reported results as negative for flu a.From the instructions for use: "the test is intended for interpretation in both laboratory and near patient testing environments only with the bd veritor plus analyzer instrument.The test is not intended to be interpreted visually." the reported issue was unable to be confirmed.The root cause could not be identified.No trend against discrepant results was identified.Currently no adverse trend for discrepant results was identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that while testing with bd veritor ¿ sars-cov-2 & flu a+b non reproduceable results were obtained.The first was positive for sars, second one was negative for all.A second bd antigen test was run.This was negative.Pcr testing was not performed.There was no patient impact.Eua# (b)(4).The following information was provided by the initial reporter: it was reported that false positive result.The first cartridge was re-run immediately after the first positive result shown on the analyzer.The positive for flu came up, then the analyzer was turn off and on and the cartridge was re-inserted again, and gave negative results.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: NOT CLASSIFIED
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14056315
• MDR Text Key: 288902479
• Report Number: 3006948883-2022-00108
• Device Sequence Number: 1
• Product Code: QMN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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
• Device Operator: Other
• Device Expiration Date: 11/04/2022
• Device Catalogue Number: 256088
• Device Lot Number: 1266197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1