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

Model Number 256045

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

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

Event Date 08/12/2021

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 physician veritor false positive results were obtained by the laboratory personnel.A repeat 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: "it was reported that customer called and reported that there was a mix up with the covid (rv reagent d) and the flu a&b cartridge.Customer said that every time she used the reagent with the flu cartridge it caused the flu a to be positive every time.".

Event Description

It was reported that while using kit flu a+b 30 test physician veritor false positive results were obtained by the laboratory personnel.A repeat 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: "it was reported that customer called and reported that there was a mix up with the covid (rv reagent d) and the flu a&b cartridge.Customer said that every time she used the reagent with the flu cartridge it caused the flu a to be positive every time.".

Manufacturer Narrative

H6: investigation summary: this statement summarizes the investigation results regarding the complaint that alleges false positive when using kit flu a+b 30 test physician veritor (material # 256045), batch number 0107717.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.An investigation and testing were performed on the batch number provided and no relevant issue was found.The complaint was unable to be confirmed via the retain samples.Technical support performed troubleshooting with the customer.The customer advised that they were using the wrong products together in the lab.Patients were retested for flu a&b the same day and all were negative.The customer informed the doctor of results and has arranged the correct products in the correct box.The root cause was traced to an ¿unintended user error caused or contributed to the event¿.A trend analysis for false positive was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

• Brand Name: KIT FLU A+B 30 TEST PHYSICIAN 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12388883
• MDR Text Key: 270063632
• Report Number: 3006948883-2021-00902
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132692
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/02/2023
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 0107717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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