MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B; 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
It was reported that during use with bd veritor system for rapid detection of flu a+b a false positive result was obtained.Confirmatory pcr testing performed and the result was negative.There was no report of patient impact.This is the 4th of 4 patients tested at this site.The following information was provided by the initial reporter: discrepant/false positive results flu a pcr confirmatory testing performed by the state lab for a total of 8 samples which all were negative for flu a by pcr but positive on the veritor.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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 numbers 2222483 & 2213636.The customer reported false positive results from 8 different patient samples at two lab sites.This complaint pertains to 4 false positive results, with 2 occurring for each of the batch numbers 2222483 & 2213636 at laconia site.The customer stated that pcr confirmatory testing was performed by the state lab, 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 numbers 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.
Event or Problem Description
It was reported that during use with bd veritor system for rapid detection of flu a+b a false positive result was obtained.Confirmatory pcr testing performed and the result was negative.There was no report of patient impact.This is 2nd of 4 patients tested at this site.The following information was provided by the initial reporter: discrepant/false positive results flu a pcr confirmatory testing performed by the state lab for a total of 8 samples which all were negative for flu a by pcr but positive on the veritor.
Event or Problem Description
It was reported that during use with bd veritor system for rapid detection of flu a+b a false positive result was obtained.Confirmatory pcr testing performed and the result was negative.There was no report of patient impact.This is the 4th of 4 patients tested at this site.The following information was provided by the initial reporter: discrepant/false positive results flu a pcr confirmatory testing performed by the state lab for a total of 8 samples which all were negative for flu a by pcr but positive on the veritor.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.B5: it was reported that during use with bd veritor system for rapid detection of flu a+b a false positive result was obtained.Confirmatory pcr testing performed and the result was negative.There was no report of patient impact.This is the 4th of 4 patients tested at this site.The following information was provided by the initial reporter: discrepant/false positive results flu a pcr confirmatory testing performed by the state lab for a total of 8 samples which all were negative for flu a by pcr but positive on the veritor.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17863014
• Report Number: 3006948883-2023-00104
• Device Sequence Number: 12295942
• Product Code: GNX
• UDI-Device Identifier: 00382902560418
• UDI-Public: 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,Followup
• Report Date (Section B): 12/04/2023

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: 11/22/2023; 11/21/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/05/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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