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

Model Number 256045

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: 0093792 was reported, however, this is not a lot# manufactured for this product.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.(b)(4).

Event Description

It was reported while testing with bd kit flu a+b 30 test physician veritor¿ 5 false positive results were obtained on asymptomatic patients.Confirmatory testing was performed using pcr test method and the results were negative.There was no report of patient impact.

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 physician veritor (mn# 256045), batch number 0093792.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.The reported issue was unable to be confirmed.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h10.

Event Description

It was reported while testing with bd kit flu a+b 30 test physician veritor¿ 5 false positive results were obtained on asymptomatic patients.Confirmatory testing was performed using pcr test method and the results were negative.There was no report of patient impact.

• Brand Name: BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR
• Type of Device: DEVICES DETECTING INFLUENZA A, B, & C VIRUS ANTIGENS
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11276754
• MDR Text Key: 232513817
• Report Number: 3006948883-2021-00183
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• PMA/PMN Number: K132692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0093792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1