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

Catalog Number 256089

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 after testing, users discovered that an incorrect component was included in a bd rapid detection of sars-cov-2 veritor¿ kit.The test gave an error message and did not provide a result.There was no report of patient impact.Eua (b)(4).The following information was provided by the initial reporter: d2 lab tech used a flu bd cartridge causing an invalid error message result on the analyzer.Lab tech re-drip on a new cartridge again.Flu bd cartridge seems to be mixed up in this current bd batch.

Manufacturer Narrative

H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges mixed product and invalid result when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1313612.Bd quality performs a systematic approach to investigate mixed product and invalid result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation including reviewing all returned photographs were performed and concluded that the flu test was introduced during the pouching process of the sars kit.A capa 1448219 was opened to address this issue.The complaint was confirmed.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that after testing, users discovered that an incorrect component was included in a bd rapid detection of sars-cov-2 veritor¿ kit.The test gave an error message and did not provide a result.There was no report of patient impact.(b)(4).The following information was provided by the initial reporter: d2 lab tech used a flu bd cartridge causing an invalid error message result on the analyzer.Lab tech re-drip on a new cartridge again.*flu bd cartridge seems to be mixed up in this current bd batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13999441
• MDR Text Key: 288705228
• Report Number: 3006948883-2022-00102
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/10/2022
• Device Catalogue Number: 256089
• Device Lot Number: 1313612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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