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

Catalog Number	256041
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	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant result when using kit flu a+b 30 test hospital veritor (material # 256041), batch number unknown.It was reported that the customer visually detected a flu b + result and the analyzer gave a flu b+ result, however the line was faint and upon re-inserting the cartridge into the analyzer, it read as flu b- (negative).The customer mentioned that the second result (flu b-) was not reported, so no impact to the patient treatment.Bd quality performs a systematic approach to investigate all discrepant result 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 testing could not be performed because the batch number was not provided.No photos or physical samples were returned; therefore, return sample analysis could not be performed.According to the report, the customer reinserted the test device into the analyzer.Bd representative advised the customer that this test is not designed to interpret the results visually and the results should only be read through analyzer, and also the same cartridge should not be reinserted.Suggested to repeat the test with a new test device, if any concerns on the results.The reported issue was unable to be confirmed.Currently, there are no adverse trends identified for discrepant result.H3 other text : see h.10.
Event or Problem Description
It was reported that while using kit flu a+b 30 test hospital veritor there was a discrepant result.No patient impact reported.

• Brand Name: KIT FLU A+B 30 TEST HOSPITAL VERITOR
• Common Device Name: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18265319
• Report Number: 3014704491-2023-00791
• Device Sequence Number: 18081786
• Product Code: GNX
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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
• Operator of Device: Other
• Device Catalogue Number: 256041
• Device Lot Number: UNKNOWN
• 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: 11/17/2023
• Initial Report FDA Received Date: 12/05/2023
• 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