MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU VERITOR SYSTEM 30 TEST JAPAN; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number 256052

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device kit flu a+b 30 test physician veritor catalog number 256045 with 510k number k112277.

Event Description

It was reported that while using kit flu veritor system 30 test (b)(6) false positive results were obtained by the laboratory personnel.A pcr test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H6: investigation summary this memo is to summarize the investigation results regarding the complaint that alleges false positive results when using kit flu veritor system 30 test japan (mn# 256052), batch number unknown.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed as no batch number was provided.The complaint was unable to be confirmed.There are no current trends against false positive complaints.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It was reported that while using kit flu veritor system 30 test japan false positive results were obtained by the laboratory personnel.A pcr test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.

Event Description

It was reported that while using kit flu veritor system 30 test japan false positive results were obtained by the laboratory personnel.A pcr test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H5: imdrf annex b grid: b12, b17; h5: imdrf annex c grid: c23; h5: imdrf annex d grid: d1101.H6: investigation summary this summarizes the investigation results regarding the complaint that alleges ¿testing gave a positive (+) result although the n line was visible, is this assessed as false positive?¿ and ¿can ra-related factors cause a false positive¿ result? when using kit flu veritor system 30 test japan (material # 256052), batch number unknown.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation could not be performed because a batch number was not provided.The complaint was unable to be confirmed.The product instruction for use (ifu) states, ¿test results are not meant to be visually determined.All test results must be determined using the bd veritor system instrument¿.Therefore, the bd veritor system analyzer must be used for interpretation of all test results.Operators should not attempt to visually interpret assay results directly from the bd veritor system test cartridge.With some specimens, up to four lines may be visible on the test device.The veritor analyzer will appropriately interpret the result.The root cause was traced to user - failure to follow instructions.In addition, the ifu does not have any information to suggest that rheumatoid arthritis (ra) will affect the flu test results.A trend analysis for false positive was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.H3 other text : see h10.

• Brand Name: KIT FLU VERITOR SYSTEM 30 TEST JAPAN
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: 11568734
• MDR Text Key: 242232205
• Report Number: 3006948883-2021-00326
• Device Sequence Number: 1
• Product Code: PSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112277
• 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,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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