MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; SEE H.10

Model Number 256045

Device Problem False Positive Result (1227)

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

Event Date 04/05/2023

Event Type  Injury  

Event Description

Patient 2 of 2.It was reported that while using the bd veritor¿ system for rapid detection of flu a+b clia-waved kit that there was false positive.The following information was provided by the initial reporter: hazard, injury or erroneous results details did erroneous results occur? yes.If yes¿detailed erroneous results (include # of errors and type): false pos flu a.1.What result did the customer obtain from the bd product? flu a pos.2.What result was the customer expecting to obtain (if different from the obtained result): flu neg.3.Was this a qc, validation, or proficiency test? no.4.Was patient treatment changed as a consequence of the issue with results? yes.5.Did the patient suffer any adverse medical consequences as a result of the change in treatment? no.Repeated sample? (see below) no.Was the cartridge rerun (re-read)? if so, how long after the initial run was the cartridge rerun (re-read)? no for either.Was the cartridge visually read? both read visually, then run on veritor as well how many specimens were discrepant (fp or fn)? 2, both pos for flu a via veritor assay could you provide the specimen identifier for each result in question? could you provide the date/time each affected specimen was initially tested? both patients.Collected and ran on (b)(6) 23 were any erroneous results reported to the doctors? yes.Was there any patient impact as a result of the false result? were any patients treated based on erroneous results? if so, did the erroneous treatment have any adverse impact to the patient(s)? treatment prescribed, but doctor contacted patients to discontinue use of medication.Can you please clarify the total number of kit boxes received and total number affected? 2 bx.Product: 256045.Lot # 2285708.What date was the specimen collected? both collected on (b)(6) 23.What date was the specimen run? both run on (b)(6) 23.Was patient symptomatic or asymptomatic? both patients were symptomatic.How was it determined to be discrepant? 1 patient was sent to hospital, flu test performed at hospital was cx.2nd patient, no repeat or confirmatory testing done, dr.Did not trust result.Customer problem: customer claims discrepant flu results for 2 patients discrepant results.

Manufacturer Narrative

D.3 common device name: antigens, cf (including cf control), influenza virus a, b, c.E.7 initial reporter addr 1: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Mdr was updated from malfunction to serious injury.Tab b and tab h were updated.H.6 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 (material # 256045), batch number 2285708.Bd quality performs a systematic approach to investigate false positive result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Based on the provided information, it was understood that customer received false positive result for 2 symptomatic patients.1 patient was sent to hospital, flu test performed at hospital was cx and no repeat or confirmatory testing done for 2nd patient, but the doctor did not trust the result.It was also noted by the customer that both the patients were prescribed medication and both patients were contacted by the doctor to not take them.Customer did not state if patients had begun taking medication.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No samples were returned; therefore, return sample analysis could not be performed.A trend analysis for false positive was conducted, no adverse trend was identified.The complaint was unable to be confirmed.The root cause could not be identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

Patient 2 of 2.It was reported that while using the bd veritor¿ system for rapid detection of flu a+b clia-waved kit that there was false positive.The following information was provided by the initial reporter: hazard, injury or erroneous results details did erroneous results occur? yes if yes¿detailed erroneous results (include # of errors and type): false pos flu a 1.What result did the customer obtain from the bd product? flu a pos 2.What result was the customer expecting to obtain (if different from the obtained result): flu neg 3.Was this a qc, validation, or proficiency test? no 4.Was patient treatment changed as a consequence of the issue with results? yes 5.Did the patient suffer any adverse medical consequences as a result of the change in treatment? no repeated sample? (see below) no was the cartridge rerun (re-read)? if so, how long after the initial run was the cartridge rerun (re-read)? no for either was the cartridge visually read? both read visually, then run on veritor as well how many specimens were discrepant (fp or fn)? 2, both pos for flu a via veritor assay could you provide the specimen identifier for each result in question? could you provide the date/time each affected specimen was initially tested? both patients collected and ran on 4/5/23 were any erroneous results reported to the doctors? yes was there any patient impact as a result of the false result? were any patients treated based on erroneous results? if so, did the erroneous treatment have any adverse impact to the patient(s)? treatment prescribed, but doctor contacted patients to discontinue use of medication can you please clarify the total number of kit boxes received and total number affected? 2 bx product: 256045 lot # 2285708 what date was the specimen collected? both collected on 4/5/23 what date was the specimen run? both run on 4/5/23 was patient symptomatic or asymptomatic? both patients were symptomatic how was it determined to be discrepant? 1 patient was sent to hospital, flu test performed at hospital was cx.2nd patient, no repeat or confirmatory testing done, dr.Did not trust result.Customer problem: customer claims discrepant flu results for 2 patients discrepant results.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16828772
• MDR Text Key: 314534155
• Report Number: 3006948883-2023-00029
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 2285708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other