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

Model Number 256045

Device Problem False Positive Result (1227)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: 0121654 was reported, however, this is not a lot number manufactured for the reported catalog number.Initial reporter phone #: (b)(6) option 1 a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with the kit flu a+b 30 test physician veritor, false positive results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports that the specimen is not flowing completely in the test device which will result in false positive flu b.Steps taken with customer/troubleshooting: review the work flow with the customer they seem to wait 1 minute longer so the specimen flow before reading it.Qc pass.Customer denies any viscosity in the specimen.They don't perform the test under the hood or where is an air flow.They test on analyze now mode.Specimen flow is delayed and flow slowly.After the 10 min incubation the specimen flows completely and they can see the control line but the background is pinkish and once they inserted it gives false positive on flu b.She states if they reinsert the test like 3 min later it will give negative results.Customer states that this happened with this lot only and that they are running a different lot now and it works fine.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges false positive result when using kit flu a+b 30 test physician veritor (material # 256045), batch number 0121654.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.An investigation and testing were performed on the batch number provided for retain and return samples with expected results.The complaint was unable to be confirmed.The root cause could not be identified.A trend analysis for false positive was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that during use with the kit flu a+b 30 test physician veritor, false positive results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports that the specimen is not flowing completely in the test device which will result in false positive flu b.Steps taken with customer/troubleshooting: review the work flow with the customer they seem to wait 1 minute longer so the specimen flow before reading it.Qc pass.Customer denies any viscosity in the specimen.They don't perform the test under the hood or where is an air flow.They test on analyze now mode.Specimen flow is delayed and flow slowly.After the 10 min incubation the specimen flows completely and they can see the control line but the background is pinkish and once they inserted it gives false positive on flu b.She states if they reinsert the test like 3 min later it will give negative results.Customer states that this happened with this lot only and that they are running a different lot now and it works fine.

• Brand Name: KIT FLU A+B 30 TEST PHYSICIAN 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: 14243181
• MDR Text Key: 299458707
• Report Number: 1119779-2022-00629
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132692
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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