MAUDE Adverse Event Report: BD (SUZHOU) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256089

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that while using bd rapid detection of sars-cov-2 veritor¿ there was one discrepant result.There was no patient impact reported.The following information was provided by the initial reporter: "evidence of 1 inconsistent result bd veritor rapid sars-cov-2 x30 256089.Lot: 2265569 expiration date: 09/08/202 antigen sample for covid-19 that is visually observed with two lines, the control line and the line indicating that the sample is positive, but when passed through the veritor equipment, the result is negative.".

Manufacturer Narrative

E.1.Initial reporter addr 1: (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.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant result when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 2265569.The customer reported that when visually observing the antigen sample for covid-19, two lines are seen (the control line and the line indicating a positive sample).However, when passed through the veritor equipment, the result is negative.They have decided to process the sample again to confirm the result.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.Batch history record (bhr) review and retain sample analysis were performed on the batch number provided.The results were acceptable, and no relevant issues were found.Based on the provided information, it was understood that the customer received a valid negative result with analyzer, and they tried to interpret the results visually based on the lines.This product is not designed to interpret the results visually and the results should only be read through analyzer.If the customer wants to confirm the result, they need to perform retest with a new cartridge or consider other methods such as pcr to determine whether the sample is positive or negative.This complaint was unable to be confirmed.Currently, there are no adverse trends identified for discrepant result.Bd quality will continue to monitor for trends.

Event Description

It was reported that while using bd rapid detection of sars-cov-2 veritor¿ there was one discrepant result.There was no patient impact reported.The following information was provided by the initial reporter: "evidence of 1 inconsistent result bd veritor rapid sars-cov-2 x30 256089, lot: 2265569, expiration date: 09/08/2023.Antigen sample for covid-19 that is visually observed with two lines, the control line and the line indicating that the sample is positive, but when passed through the veritor equipment, the result is negative.".

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• 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: 17287928
• MDR Text Key: 318959219
• Report Number: 3014704491-2023-00328
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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
• Device Operator: Other
• Device Expiration Date: 09/08/2023
• Device Catalogue Number: 256089
• Device Lot Number: 2265569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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