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

Catalog Number 256082

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

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that while using bd rapid detection of sars-cov-2 veritor¿ the test was read by the analyzer, 4 times within 5 minutes, and got three negative and one positive result.Customer is not certain in which order.The patient is symptomatic.No patient impact reported.Eua (b)(4).

Manufacturer Narrative

G5.Pma / 510(k)#: eua # (b)(4).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

H6.Investigation summary: this summarizes the investigation results regarding a complaint that alleges discrepant results when using kit rapid detection of sars-cov-2 veritor (material # (b)(4)), batch number 3179126.The customer reported that the reagents were brought to the employee's home, where they ran the test, got 3 lines, then they called the facility for help to interpret the result; facility wasn't sure, so someone brought the analyzer to the employee's home in about 1 hour.The test device was inserted into the analyzer 4 times within 5 minutes.The 4 results they got were 3 negatives and 1 positive on the symptomatic patient sample.The customer was not aware that the test results are not meant to be visually determined.They stated that they don't have the capacity to read each test device with an instrument.Bd quality performs a systematic approach to investigate discrepant result complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No photos or samples were received; therefore, return sample analysis could not be performed.Bd representative advised the customer that this product is not designed to interpret the results visually and the results should only be read through analyzer, and also the same cartridge should not be reinserted.This complaint was unable to be confirmed.No trend against discrepant results was identified.Bd quality will continue to closely monitor for trends.H3 other text : see h10.

Event Description

It was reported that while using bd rapid detection of sars-cov-2 veritor¿ the test was read by the analyzer, 4 times within 5 minutes, and got three negative and one positive result.Customer is not certain in which order.The patient is symptomatic.No patient impact reported.(b)(4).

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18220026
• MDR Text Key: 329154199
• Report Number: 3006948883-2023-00118
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00382902560821
• UDI-Public: (01)00382902560821
• 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: 12/09/2023

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: Lay User/Patient
• Device Expiration Date: 03/06/2024
• Device Catalogue Number: 256082
• Device Lot Number: 3179126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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