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 Expiration Date Error (2528)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Eua # (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 while testing for sars-cov-2 the expiration date of the positive qc swab expires 2021-04-07, however, the expiration date of the kit is 2021-06-19.Eua # (b)(4).It was reported that positive qc swab expires earlier than the date printed outside of the carton.Customer stated in the email that she noticed the expiry date for the positive qc swab expires on 4/7/21 but the expiry date printed outside of the carton is 6/19/21.If consumable is tested on bd instrumentation, list serial numbers: (b)(4).Shipment method (directly or via distributor): distributor.If it is a distributor ¿ who is it? thermofisher.Indication that customer is industrial indu (if applicable): clinical.

Event Description

It was reported while testing for sars-cov-2 the expiration date of the positive qc swab expires 2021-04-07, however, the expiration date of the kit is 2021-06-19 eua # 201889 it was reported that positive qc swab expires earlier than the date printed outside of the carton.Customer stated in the email that she noticed the expiry date for the positive qc swab expires on 4/7/21 but the expiry date printed outside of the carton is 6/19/21.¿ if consumable is tested on bd instrumentation, list serial numbers: (b)(6) and (b)(6) ¿ shipment method (directly or via distributor): distributor ¿ if it is a distributor ¿ who is it? thermofisher ¿ indication that customer is industrial indu (if applicable): clinical.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges positive qc swab expired material when using bd kit veritor for rapid detection of sars-cov-2 (mn# 256082), batch number 1011283.Bd quality performs a systematic approach to investigate positive qc swab expired material complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.A batch review was performed for the number provided.The reported issue was unable to be confirmed.The retention testing could not be tested as they are expired.Returned product testing could not be completed as samples are expired.There are no current trends against positive qc swab expired material.However, the returned photographic evidence provided confirms the customer's report of positive qc swab expired material.Bd quality will continue to closely monitor for trends.See h.10.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11696083
• MDR Text Key: 268500474
• Report Number: 3006948883-2021-00406
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/09/2021

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: 06/19/2021
• Device Catalogue Number: 256082
• Device Lot Number: 1011283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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