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

Catalog Number 256089

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the rapid detection of sars-cov-2 veritor experienced a false positive.Confirmatory testing was performed using pcr swab method and the result was positive.There was no report of patient impact.The following information was provided by the initial reporter: the result showed positive with a pink patch, looks abnormal to user.What type of reference method was used to confirm the result (pcr, viral culture, etc)? customer was sent for pcr swab.What is the result of the confirmatory test? not reveal by customer.How many specimens were discrepant? 1.If yes, were any patients treated based on erroneous results? no.If yes, did the erroneous treatment have any adverse impact to the patient(s)? no.

Event Description

It was reported that the rapid detection of sars-cov-2 veritor experienced a false positive.Confirmatory testing was performed using pcr swab method and the result was positive.There was no report of patient impact.The following information was provided by the initial reporter: the result showed positive with a pink patch, looks abnormal to user.¿ what type of reference method was used to confirm the result (pcr, viral culture, etc)? customer was sent for pcr swab.¿ what is the result of the confirmatory test? not reveal by customer ¿ how many specimens were discrepant? 1 ¿ if yes, were any patients treated based on erroneous results? no ¿ if yes, did the erroneous treatment have any adverse impact to the patient(s)? no.

Manufacturer Narrative

H6: investigation summary this statement is to summarize the investigation results regarding the complaint that alleges positive with a pink patch when using rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1020841.Bd quality performs a systematic approach to investigate positive with a pink patch complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.The reported issue was unable to be confirmed.The root cause could not be identified.A photograph was returned and showed positive with a pink patch.Bd quality will continue to closely monitor for trends.: see h10.

• Brand Name: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12449946
• MDR Text Key: 271094983
• Report Number: 3006948883-2021-00915
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/25/2021
• Device Catalogue Number: 256089
• Device Lot Number: 1020841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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