MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU A+B 30 TEST HOSPITAL VERITOR; SEE H.10

Model Number 256041

Device Problem False Positive Result (1227)

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

Event Date 04/03/2023

Event Type  Injury  

Event Description

Report 3 of 8.It was reported that while using kit flu a+b 30 test hospital veritor influenza a false positive occurred.Patient was hospital for extended period, no treatment information was provided.The following information was provided by the initial reporter: evidence of 8 false positive results in veritor plus flu a+b compared with pcr performed by the d p h laboratory.Most of them correspond to detection of flu a: positive with pcr: negative.Treatment information could not be obtained.The hospital stay increased.

Manufacturer Narrative

Common device name: devices detecting influenza a, b, and c virus antigens initial reporter email: (b)(6).Customer provided two lots 0167930 and 0273900, however the customer can not confirm which lot happened on which patient.Reporting both lots for each patient.The information for each additional lot number is as follows: medical device lot#: 0167930.Medical device expiration date: 24-apr-2023.Device manufacture date: 15-jun-2020.Medical device lot#: 0273900.Medical device expiration date: 27-may-2023.Device manufacture date: 29-sep-2020.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges customer received multiple false positive results when using kit flu a+b 30 test hospital veritor (material # 256041), batch number 0167930 & 0273900 (customer also reported lot# 0183766, which is a test cartridge and used to make kit lot number 0273900).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.Based on the provided information, it was understood that the customer received multiple false positive results with veritor plus flu a+b.The results were compared with pcr performed by the d p h laboratory.Most of them resulted in negative results.According to the data provided by the customer, 3 reports were showing molecular confirmation tests of 3 patients.It was not possible to link the lot with each false positive result.Date of occurrence for each batch was not possible to be linked with the available information, so it was possible to identify these false positives results.Upon follow-up with the customer in relation to the procedure used, it was identified that a possible factor that could affect the result was that the customer used repackaged saline solution and maximum time of referral of samples to lsp of 72 hours, specialist reported that there was no known stability of the pcr test in saline solution.It is recommended not to use repackage saline solution.A batch history record (bhr) review and retention testing were performed on batch number provided.The results were acceptable, and no relevant issues were identified.No physical samples were returned; therefore, return sample analysis could not be performed.Customer sent images of veritor test results, which shown patients got positive results.The reported issue was confirmed based on the data provided by the customer.Currently, there are no adverse trends identified for false positive.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

Report 3 of 8.It was reported that while using kit flu a+b 30 test hospital veritor influenza a false positive occurred.Patient was hospital for extended period, no treatment information was provided.The following information was provided by the initial reporter: evidence of 8 false positive results in veritor plus flu a+b compared with pcr performed by the d p h laboratory.Most of them correspond to detection of flu a: positive with pcr: negative.Treatment information could not be obtained.The hospital stay increased.

• Brand Name: KIT FLU A+B 30 TEST HOSPITAL VERITOR
• Type of Device: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16845323
• MDR Text Key: 314302640
• Report Number: 1119779-2023-00508
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560418
• UDI-Public: 00382902560418
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K133138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256041
• Device Catalogue Number: 256041
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR
• Patient Sex: Male