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

Catalog Number 256052

Device Problem False Positive Result (1227)

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

Event Date 02/02/2022

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.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device kit flu a+b 30 test physician veritor catalog number 256045 which has 510k number k112277.

Event Description

It was reported that while using kit flu veritor system 30 test japan false positive results were obtained by the laboratory personnel.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: "this is a report about a false positive.According to the customer's report, the result appears to be positive with a sample which is supposedly negative.".

Event Description

It was reported that while using kit flu veritor system 30 test japan false positive results were obtained by the laboratory personnel.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: "this is a report about a false positive.According to the customer's report, the result appears to be positive with a sample which is supposedly negative.".

Manufacturer Narrative

H6: investigation summary: this memo is to summarize the investigation results regarding the complaint that alleges false positive when using kit flu veritor system 30 test japan (material # 256052), 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 as no batch number was provided.A photograph was returned and showed two kit flu veritor system 30 test japan test device with results and unable to confirm of false positive.The reported issue was unable to be confirmed.There are no current trends against false positive.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

• Brand Name: KIT FLU VERITOR SYSTEM 30 TEST JAPAN
• 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: 13641122
• MDR Text Key: 286596288
• Report Number: 3006948883-2022-00046
• Device Sequence Number: 1
• Product Code: PSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• 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