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	06/01/2021
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.
Event or Problem Description
It was reported that while using kit rsv 30 test physician veritor false positive reuslts were obtained by the laboratory personnel.An asan 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.The following information was provided by the initial reporter: " after processing sample was added in to the bd veritor rsv cartridge.After incubation time, 3 lines were appeared on the cartridge, and veritor plus analysis gave positive result.".
Event or Problem Description
It was reported that while using kit rsv 30 test physician veritor false positive reuslts were obtained by the laboratory personnel.An asan 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.The following information was provided by the initial reporter: " after processing sample was added in to the bd veritor rsv cartridge.After incubation time, 3 lines were appeared on the cartridge, and veritor plus analysis gave positive result.".
Additional Manufacturer Narrative
H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges multiple lines on the test cartridge results when using kit rsv 30 test physician veritor (material # 256038), batch number 0142557.Bd quality performs a systematic approach to investigate multiple lines on the test cartridge 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 number provided.The reported issue was unable to be confirmed.The returned photographic provided confirms with the report of multiple lines on the test cartridge.No trend against failed multiple lines on the test cartridge was identified.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h.10.

• 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: 12111640
• Report Number: 3006948883-2021-00727
• Device Sequence Number: 19759186
• 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): 12/09/2021

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: 03/08/2022
• Device Model Number: 256038
• Device Catalogue Number: 256038
• Device Lot Number: 0142557
• 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: 06/07/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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