MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIT FLU A+B 30 TEST HOSPITAL VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Model Number 256041

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

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd kit flu a+b 30 test hospital veritor false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.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: " costumer reports a discrepant results" costumer perform tree times the test whit the same sample and one result give positive the other negatives, they test the patient again and the result was different to the initial if media performance issue provide organism atcc strain information (if applicable): steps taken with customer/troubleshooting: request additional information.Next steps (if necessary): send the questionnaire.Resolution achieved (y/n)? : n.Quantity received and quantity affected: pending.Shipment method (directly or via distributor): pending.If it is a distributor or directly from bd ¿ who is it?: pending.Photos or returns requested?: pending to confirm.Follow up required y/n?: yes.If consumable is tested on bd instrumentation, list serial numbers: (b)(4).Time stamp (if applicable): na.Indication that customer is industrial indu (if applicable): na.Reviewed smax case history: y.Help lightning attempt:n.Help lightning success:n.(b)(6) : (b)(6) 2021 18:06:23 (gmt).Subject: email (b)(6) 2021, 11:25:29 am.User: (b)(6).Created on: (b)(6)2021 17:25:29.Call activity comment: request additional information.(b)(6) : (b)(6) 2021 14:13:56 (gmt).Subject: call (b)(6) 2021, 7:35:31 am.User: (b)(6).Created on: (b)(6) 2021 13:35:32.Call activity comment: discrepant results.(b)(6) : (b)(6) 2021 13:45:16 (gmt).Discrepant results.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges discrepant results when using kit flu a+b 30 test hospital veritor (material # 256041) batch number unknown.Bd quality performs a systematic approach to investigate discrepant results 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 reported issue was unable to be confirmed.The root cause could not be identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that while using bd kit flu a+b 30 test hospital veritor false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.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: " costumer reports a discrepant results" costumer perform tree times the test whit the same sample and one result give positive the other negatives, they test the patient again and the result was different to the initial if media performance issue provide organism atcc strain information (if applicable): steps taken with customer/troubleshooting: request additional information.Next steps (if necessary): send the questionnaire.Resolution achieved (y/n)? : no.Quantity received and quantity affected: pending.Shipment method (directly or via distributor): pending.If it is a distributor or directly from bd ¿ who is it?: pending.Photos or returns requested?: pending to confirm.Follow up required y/n?: yes.If consumable is tested on bd instrumentation, list serial numbers: (b)(6).Time stamp (if applicable): na.Indication that customer is industrial indu (if applicable): na.Reviewed smax case history: yes.Help lightning attempt:no.Help lightning success:no.(b)(6) : (b)(6) 2021 18:06:23 (gmt).Subject: email (b)(6) 2021, 11:25:29 am.User: (b)(6).Created on: (b)(6) 2021 17:25:29.Call activity comment: request additional information.(b)(6) : (b)(6) 202114:13:56 (gmt).Subject: call (b)(6) 2021, 7:35:31 am.User: (b)(6).Created on: (b)(6) 2021 13:35:32.Call activity comment: discrepant results.(b)(6) : (b)(6) 2021 13:45:16 (gmt).Discrepant results.

• Brand Name: BD KIT FLU A+B 30 TEST HOSPITAL VERITOR
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13154945
• MDR Text Key: 290544187
• Report Number: 1119779-2021-02071
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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: 03/02/2022
• 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