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 (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Catalog Number 256045

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit contamination was found and is causing abnormal test results.The following information was provided by the initial reporter: black spots were found when reagents were dropped in the reading area, causing abnormal readings.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated with corrected information: b.5.Describe event or problem: it was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit contamination was found and is causing false positive results.This occurred with 4 devices.Confirmation testing completed and results were negative.Patient information and impact was not reported.The following information was provided by the initial reporter: black spots were found when reagents were dropped in the reading area, causing abnormal readings h.6 imdrf annex a codes: a090804 and a180104 h.6 investigation summary this statement is to summarize the investigation results regarding the complaint that involving kit flu a+b 30 test physician veritor.The customer reported that the black spots were found when reagents were dropped in the reading area, which causing abnormal readings.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.The customer has provided a photograph confirming black spot in the test window of cartridge.Additionally, another photograph of veritor flu test result taken with a veritor reader was provided by the customer.The test result indicated a positive for flu a, but the pcr result was negative.This complaint was confirmed based on the photographic evidence.The root cause could not be determined.A trend analysis for false positive and contamination / foreign matter was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit contamination was found and is causing false positive results.This occurred with 4 devices.Confirmation testing completed and results were negative.Patient information and impact was not reported.The following information was provided by the initial reporter: black spots were found when reagents were dropped in the reading area, causing abnormal readings.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: ANTIGENS, CF (INCLUDING 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
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17492293
• MDR Text Key: 320723418
• Report Number: 3014704491-2023-00433
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K132692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256045
• Device Lot Number: 3142973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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