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

Model Number 256041

Device Problem False Positive Result (1227)

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

Event Date 11/06/2021

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 flu a+b 30 test hospital veritor 3 false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.The customer stated there was no patient impact.The following information was provided by the initial reporter: " it was reported that customer reporting false positives with ver 256041 test kit lo 0051984.".

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges false positive results when using kit flu a+b 30 test hospital veritor (material # 256041), batch number 0051984.Bd quality performs a systematic approach to investigate false positive result 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.Returned product testing was completed and all devices tested had normal intended results.No trend against false positive results was identified.The root cause could not be identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that while using kit flu a+b 30 test hospital veritor 3 false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.The customer stated there was no patient impact.The following information was provided by the initial reporter: "it was reported that customer reporting false positives with ver 256041 test kit lo 0051984".

• Brand Name: KIT FLU A+B 30 TEST HOSPITAL VERITOR
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12972547
• MDR Text Key: 289742355
• Report Number: 3006948883-2021-01020
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: 00382902560418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/08/2023
• Device Model Number: 256041
• Device Catalogue Number: 256041
• Device Lot Number: 0051984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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