MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; ANTIGENS, CF (INC CF CONTROL) INFLUENZA VIRUS A, B, C

Model Number 256045

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported while testing with bd veritor system for rapid detection of flu a+b clia-waved kit false positive results were obtained.Confirmatory testing was performed using pcr test method and the results were negative.Some patients received tamiflu or other antiviral.

Manufacturer Narrative

H6: investigation summary: bd point of care quality initiated investigation on the customer report regarding alleged false positive when using the kit flu a+b 30 test physician veritor (ref# 256045).Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.There was no lot number documented in the submission of this complaint; therefore no internal investigations can be performed and the issue cannot be confirmed.No returns were received to investigate.The investigation did not find a root cause for the false positive results reported.In a follow-up, customer indicated that the issue was resolved by vortexing the specimen and running the specimen without delay.Bd cannot confirm the complaint based on the investigation that was performed.Bd point of care will continue to closely monitor for trends associated with false positive when using the kit flu a+b 30 test physician veritor (ref# 256045).There was no corrective action taken at this time.

Event Description

It was reported while testing with bd veritor¿ system for rapid detection of flu a+b clia-waved kit false positive results were obtained.Confirmatory testing was performed using pcr test method and the results were negative.Some patients received tamiflu or other antiviral.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: ANTIGENS, CF (INC CF CONTROL) INFLUENZA VIRUS A, B, C
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11375812
• MDR Text Key: 233455069
• Report Number: 3006948883-2021-00257
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• PMA/PMN Number: K112277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1