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

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

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

Event Date 06/01/2021

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.

Event 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 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.".

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
• Type of Device: 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
• MDR Text Key: 260106413
• Report Number: 3006948883-2021-00727
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: 00382902560388
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K132456
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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