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

Model Number	662878
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported while testing for sars cov-2 a false positive result was obtained.The patient was retested on the veritor and the result was negative.The customer stated they are testing asymptomatic patients.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, and there was no report of patient impact.Eua#: (b)(4).
Event or Problem Description
It was reported while testing for sars cov-2 a false positive result was obtained.The patient was retested on the veritor and the result was negative.The customer stated they are testing asymptomatic patients.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 and there was no report of patient impact.Eua#: eua201889.
Additional Manufacturer Narrative
H.6.Investigation: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records for batch number 0246062 testing of retention samples of batch number 0246062, and testing of customer returned samples if applicable.The investigation did not find a root cause for the false positive results that were observed.The root cause is under investigation and will be documented in our quality system.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.H3 other text : see h.10.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 10788311
• Report Number: 3006948883-2020-00700
• Device Sequence Number: 4012182
• Product Code: QKP
• UDI-Device Identifier: 00382906628787
• UDI-Public: 00382906628787
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Operator of Device: Other
• Device Expiration Date: 01/12/2021
• Device Model Number: 662878
• Device Catalogue Number: 256082
• Device Lot Number: 0246062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1