MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU A+B 30 TEST HOSPITAL VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number	256041
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report 1 of 4.It was reported that while using kit flu a+b 30 test hospital veritor patient sample was read as positive however pcr confirmatory testing was negative.The following information was provided by the initial reporter: discrepant/false positive results flu a did the customer visually interpret the result or did they insert into the analyzer to determine the result? result read by the analyzer what type of reference method was used to confirm the result (pcr, viral culture, etc)? pcr confirmatory testing performed by the state lab for a total of 4 samples which all were negative for flu a by pcr but positive on the veritor.
Additional Manufacturer Narrative
H.3.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
Report 1 of 4 it was reported that while using kit flu a+b 30 test hospital veritor patient sample was read as positive however pcr confirmatory testing was negative.The following information was provided by the initial reporter: discrepant/false positive results flu a did the customer visually interpret the result or did they insert into the analyzer to determine the result? result read by the analyzer what type of reference method was used to confirm the result (pcr, viral culture, etc)? pcr confirmatory testing performed by the state lab for a total of 4 samples which all were negative for flu a by pcr but positive on the veritor.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive results when using kit flu a+b 30 test hospital veritor (material # 256041), batch number 2213636.The customer reported false positive results from 8 different patient samples at two lab sites (4 false positive results for batch# 2213636 at 1 site).They stated that pcr confirmatory testing was performed by the state lab for a total of 8 samples, all of which tested negative for flu a on pcr but positive on the veritor.Bd quality performs a systematic approach to investigate all false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.A batch history record (bhr) review and retention testing were performed on the batch number provided.The results were acceptable, and no relevant issues were identified.No photos or physical samples were returned; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.Currently, there are no adverse trends identified for false positive.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

• Brand Name: KIT FLU A+B 30 TEST HOSPITAL VERITOR
• Common Device Name: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17877320
• Report Number: 3014704491-2023-00627
• Device Sequence Number: 4386770
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2023

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: 05/15/2025
• Device Catalogue Number: 256041
• Device Lot Number: 2213636
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 11/05/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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