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 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. 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 false positive result was obtained. A repeat test was performed using either the pcr method or the cepheid genexpert method. Upon repeat, the result was negative. The customer stated the patient tested was asymptomatic. This test is not intended for use on asymptomatic patients and was therefore used off label. 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: 11141123
• Report Number: 3006948883-2021-00035
• 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: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/15/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0275996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial