MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT RSV 30 TEST PHYSICIAN VERITOR; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Model Number	256038
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0013102.Medical device expiration date: 2022-10-16.Device manufacture date: 2020-01-13.Medical device lot #: 0142557.Medical device expiration date: 2022-03-08.Device manufacture date: 2020-05-21.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using 4 kit rsv 30 test physician veritor false negative results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one patients was took sample 2 times.1 sample as test in 2 cartridge.The 1st samples was took and test with: + 1 st cartridge ( lot 0142775) and labelled as 480871 - l1.Results: 3 lines on cartridge - reader gave neg.+ after that 2nd cartridge ( lot 0142775) was tried it was labelled as 480871 - l2.Results: 3 lines on cartridge - reader gave pos.".
Additional Manufacturer Narrative
H6: investigation summary this statement summarizes the investigation results regarding your complaint that alleges false negative when using kit rsv 30 test physician veritor (material # 256038), batch numbers 0013102, 0142557.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch numbers provided and no relevant issue was found.The complaint was unable to be confirmed via the retain samples.Photos were provided.The photos confirmed the reported multiple lines complaint issue.The bd veritor system instrument (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 strip (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 failure to follow instructions.A trend analysis for false negative was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.
Event or Problem Description
It was reported that while using 4 kit rsv 30 test physician veritor false negative results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one patients was took sample 2 times.1 sample as test in 2 cartridge.The 1st samples was took and test with: 1 st cartridge ( lot 0142775) and labelled as 480871 - l1.Results: 3 lines on cartridge - reader gave neg.After that 2nd cartridge ( lot 0142775) was tried it was labelled as 480871 - l2.Results: 3 lines on cartridge - reader gave pos.".

• Brand Name: KIT RSV 30 TEST PHYSICIAN VERITOR
• Common Device Name: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12197305
• Report Number: 3006948883-2021-00815
• Device Sequence Number: 3036268
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: 00382902560388
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K132456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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 Model Number: 256038
• Device Catalogue Number: 256038
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown