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

Model Number 256042

Device Problem False Positive Result (1227)

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

Event Date 04/03/2023

Event Type  Injury  

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 Description

Report 1 of 2.It was reported that while using the bd veritor system rsv assays a false positive 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: evidence of 1 false positive result in veritor plus (respiratory syncytial virus-rsv) compared to a pcr study carried out by the city's public health laboratory.Lot: 1123929 secondary analysis by another reference laboratory through molecular analysis (pcr).

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 # (b)(6), batch number (b)(6).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.

Event Description

Report 1 of 2.It was reported that while using the bd veritor system rsv assays a false positive 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: evidence of 1 false positive result in veritor plus (respiratory syncytial virus-rsv) compared to a pcr study carried out by the city's public health laboratory.Lot: 1123929 secondary analysis by another reference laboratory through molecular analysis (pcr).

• Brand Name: BD VERITOR SYSTEM RSV ASSAYS
• Type of Device: 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: 16845430
• MDR Text Key: 314360317
• Report Number: 3014704491-2023-00157
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K133140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 1 YR
• Patient Sex: Female