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 Inaccurate Information (4051)

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

Event Date 03/25/2021

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 while using bd rapid detection of sars-cov-2 veritor¿ the positive qc swab was discovered to be expired, while the kits expiration was still valid.There was no report of patient impact.(b)(4).The following information was provided by the initial reporter: the customer is indicating that the positive qc swab is expired, even though 256082 expiration date is still valid.The customer indicated that the facility mixed up the qc swab for 256082 lot number 0329101.Bd did not issue out a kit with an expired qc swab.They no longer want to pursue an investigation.They have rectified the issue and this matter does not need any further assistance.The facility made an error with the kits qc swabs and have rectify the situations.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00398 was sent in error.There was a mix up in customers lab, the qc swab used was from another kit, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd rapid detection of sars-cov-2 veritor¿ the positive qc swab was discovered to be expired, while the kits expiration was still valid.There was no report of patient impact.Eua # (b)(4).The following information was provided by the initial reporter: the customer is indicating that the positive qc swab is expired, even though 256082 expiration date is still valid.The customer indicated that the facility mixed up the qc swab for 256082 lot number 0329101.Bd did not issue out a kit with an expired qc swab.They no longer want to pursue an investigation.They have rectified the issue and this matter does not need any further assistance.The facility made an error with the kits qc swabs and have rectify the situations.

• 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: 11678516
• MDR Text Key: 264976417
• Report Number: 3006948883-2021-00398
• 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: 04/22/2021

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: 04/15/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0329101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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