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 Inaccurate Information (4051)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 incorrect label information was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " it was reported that typos in sds occurred.Reagent c also has a warnings listed in package insert (h302,h402,h412).Customer requests corrected sds.Customer reports typo on sds wit reagent c being listed as reagent d".

Manufacturer Narrative

H6: investigation summary: this memo is to summarize the investigation results regarding the complaint that alleges typo on sds with reagent c being listed as reagent d when using kit flu a+b 30 test hospital veritor (material # 256041), batch number unknown.Bd quality performs a systematic approach to investigate labeling issues.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation was performed.The complaint was confirmed.The customer was supplied with an updated safety data sheet.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that while using kit flu a+b 30 test hospital veritor incorrect label information was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " it was reported that typos in sds occurred.Reagent c also has a warnings listed in package insert (h302,h402,h412).Customer requests corrected sds.Customer reports typo on sds wit reagent c being listed as reagent d".

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11653758
• MDR Text Key: 251256253
• Report Number: 3006948883-2021-00380
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256041
• Device Catalogue Number: 256041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1