MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM FOR RSV ASSAYS

Model Number	256042
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.6 initial reporter email: (b)(6).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 2 of 2 it was reported that while using the bd veritor system for rsv assays that there was a false negative was obtained, confirmation was done by pcr.Patient hospital stay was extended, no treatment information was provided.The following information was provided by the initial reporter: rsv (respiratory syncytial virus-rsv) false negative secondary analysis by another reference laboratory through molecular analysis (pcr).
Additional Manufacturer Narrative
H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive and false negative result when using kit rsv 30 test hospital veritor (material # 256042, batch number 1123929.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Based on the provided information, it was understood that the customer received one false positive and one false negative result with veritor.The results were compared with a secondary analysis by another reference laboratory through molecular analysis (pcr).Upon follow-up with the customer in relation to the procedure used, it was identified that a possible factor that could affect the result was that the customer used repackaged saline solution and maximum time of referral of samples to lsp of 72 hours, specialist reported that there was no known stability of the pcr test in saline solution.It is recommended not to use repackage saline solution.A batch history record (bhr) review and retention testing were performed on batch number provided.Results were acceptable and no relevant issues were found.No physical samples were returned; therefore, return sample analysis could not be performed.Customer sent images of veritor test results and pcr analysis report which confirmed the reported issue.This complaint was confirmed based on the data provided by the customer.Currently, there are no adverse trends identified for the reported issue.H3 other text : see h.10.
Event or Problem Description
Report 2 of 2.It was reported that while using the bd veritor system for rsv assays that there was a false negative was obtained, confirmation was done by pcr.Patient hospital stay was extended, no treatment information was provided.The following information was provided by the initial reporter: rsv (respiratory syncytial virus-rsv) false negative secondary analysis by another reference laboratory through molecular analysis (pcr).

• Brand Name: BD VERITOR SYSTEM FOR RSV ASSAYS
• Common Device Name: NA
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16845427
• Report Number: 3014704491-2023-00156
• Device Sequence Number: 18021607
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 07/07/2023
• Device Model Number: 256042
• Device Catalogue Number: 256042
• Device Lot Number: 1123929
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 2 YR
• Patient Sex: Male