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 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that there was a mix up with the covid (rv reagent d) and flu a&b cartidge in the laboratory when using kit flu a+b 30 test physician veritor and 5 false positive results were obtained.Customer stated that the covid reagent and flu reagent look identical and it was hard to distinguish the two.The patients were told they were positive for flu a, however, customer was unsure if they were treated.The following information was provided by the initial reporter: 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.Customer got 5 erroneous results.

Event Description

It was reported that there was a mix up with the covid (rv reagent d) and flu a&b cartidge in the laboratory when using kit flu a+b 30 test physician veritor and 5 false positive results were obtained.Customer stated that the covid reagent and flu reagent look identical and it was hard to distinguish the two.The patients were told they were positive for flu a, however, customer was unsure if they were treated.The following information was provided by the initial reporter: 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.Customer got 5 erroneous results.

Manufacturer Narrative

H.6.Investigation: this statement summarizes the investigation results regarding your complaint that alleges false positive results when using kit flu a+b 30 test physician veritor (material # 256045), batch number unknown.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 could not be performed because a batch number was not provided.The complaint was unable to be confirmed.Customer reported that there was a mix up in their lab with the covid reagent and the flu a&b cartridge.They realized they were using the wrong products together when they kept getting a positive flu a result on every test.The customer notified the doctor know about the mistake made in the lab.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.H3 other text : see h.10.

• 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: 12407993
• MDR Text Key: 270573968
• Report Number: 3006948883-2021-00909
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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