MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256088

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

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that bd veritor ¿ sars-cov-2 & flu a+b gave an increased flu b positivity rate.Doctor (asymptomatic) tested himself and was false positive for flu b.Customer cleaned work area in accordance with technical services recommendations and issue was resolved.Customer was followed up with to request information on patient impact.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.G5: pma/510(k)#: item is also eua - (b)(4).

Manufacturer Narrative

H6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive result when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch numbers 3198712.The customer reported an increased flu b positive rate with veritor test.The doctor (asymptomatic) tested himself, and was positive for flu b.He used the same reagent tube for the repeat test, and it came up positive for flu a and covid.Verification cartridge was used, analyzer passed the vc test.New analyzer also kept showing the same issue - increased positivity for flu b.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.Batch history record (bhr) review and retain sample analysis were performed on the batch number provided.Results were acceptable and no relevant issue was found.This complaint was unable to be confirmed.Currently no adverse trend for false positive was identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that bd veritor ¿ sars-cov-2 & flu a+b gave an increased flu b positivity rate.Doctor (asymptomatic) tested himself and was false positive for flu b.Customer cleaned work area in accordance with technical services recommendations and issue was resolved.Customer was followed up with to request information on patient impact.Eua203152.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18219984
• MDR Text Key: 330556942
• Report Number: 3006948883-2023-00111
• Device Sequence Number: 1
• Product Code: QMN
• UDI-Device Identifier: 00382902580881
• UDI-Public: (01)00382902580881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2023

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 Catalogue Number: 256088
• Device Lot Number: 3198712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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