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 07/27/2022

Event Type  malfunction  

Event Description

It was reported that while using bd veritor ¿ sars-cov-2 & flu a+b the customer keeps getting false positives for flu a.Pcr was used as confirmatory testing.No patient impact reported.The following information was provided by the initial reporter: customer keeps getting fp for flu a on the triplex assay (lot #1298462).

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch number 1298462.However, the pcr turned out to be negative for about 10 tests.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing were performed on the batch number provided.Results were acceptable and no relevant issue was found.Returned product testing was completed and all devices had normal intended results.Review of risk management documentation indicates that the potential risk of the reported complaint (false positive) was assessed as severity s3 (reference line # 39) via document sdpocrm256088aph, rev 02.The complaint was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for false positive was identified.Bd quality will continue to closely monitor for trends.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that while using bd veritor ¿ sars-cov-2 & flu a+b the customer keeps getting false positives for flu a.Pcr was used as confirmatory testing.No patient impact reported.The following information was provided by the initial reporter: customer keeps getting fp for flu a on the triplex assay (lot #1298462).

• 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: 15544776
• MDR Text Key: 303260044
• Report Number: 3006948883-2022-00180
• 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: 11/29/2022

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: 02/02/2023
• Device Catalogue Number: 256088
• Device Lot Number: 1298462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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