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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

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.(b)(4).

Event Description

It was reported while testing for sars cov-2 a potential false positive result was obtained.The customer stated they sent the positive sample out for pcr testing, and the result is unknown at this time.Bd has attempted to contact the customer multiple times for additional information regarding this event with no response from the customer at this time.There was no indication that results were reported out, or any report of patient impact.(b)(4).

Manufacturer Narrative

The following fields have been updated: g.D.Date received by manufacturer: 2020-10-15.

Event Description

It was reported while testing for sars cov-2 a potential false positive result was obtained.The customer stated they sent the positive sample out for pcr testing, and the result is unknown at this time.Bd has attempted to contact the customer multiple times for additional information regarding this event with no response from the customer at this time.There was no indication that results were reported out or any report of patient impact.Eua201889.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/12/2020.H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges negative control lines visible on a cartridge when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number 0240155.Bd quality performs a systematic approach to investigate negative control swab failure 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.Returned materials were past expiry and will not be tested.No trend against invalid results was identified.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h.10.

Event Description

It was reported while testing for sars cov-2 a potential false positive result was obtained.The customer stated they sent the positive sample out for pcr testing, and the result is unknown at this time.Bd has attempted to contact the customer multiple times for additional information regarding this event with no response from the customer at this time.There was no indication that results were reported out or any report of patient impact.Eua(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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10782331
• MDR Text Key: 214610185
• Report Number: 3006948883-2020-00686
• 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,Followup
• Report Date: 10/25/2021

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: 01/10/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0240155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 10/25/2021
• Supplement Dates FDA Received: 11/09/2020; 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2020
• 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