MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS; FLU LAB KIT

Catalog Number 256041

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: at bd, we take a systematic multi-step approach to investigating customer concerns about our bd veritor assay kits.Our first step is to search for any indication of a lot-specific problem that could have contributed to the issue you observed.We examine the relevant manufacturing batch records, and then use test standards to evaluate the performance of kits retained from the specific lot in question.The results of this investigation are as follows: we examined the manufacturing batch history record for kit lot number 8326716 and we found no discrepant issues in our documentation that relate to this complaint.We evaluated retention kits, lot number 8326716, by testing sensitivity performance with flu a and flu b antigen.The tests showed normal, expected results that met product specifications.The second step in our investigation is to evaluate any products you return to us, to determine whether we can replicate in our r&d labs the issue you observed.The results of this investigation are as follows: devices tested from customer returned kit, lot number 8326716, could not replicate the false positive test results cited in the incident report.Because no instruments or patient specimens were returned, we were unable to perform this step in the investigation.Finally, if we are unable to replicate the circumstances that generated your concern, we evaluate the results of our investigation along with all of the information you provided in light of our experience with these products and with other customers, to generate a list of suggestions for you to consider.The following are factors can lead to erroneous test results: non-specific binding ¿ the presence of interfering substances, such as human anti-mammalian antibodies (hama), can cause a false positive result.Usually 3-4 lines are visible on the test membrane.Confirmation testing is recommended for these types of specimens.Transport media ¿ transport media is specifically designed for cell growth, and components that are added to nourish cells can also slow the flow of fluid along a membrane.Bd releases veritor flu a+b laboratory kits only after rigorous testing against qc criteria using viscous transport media.However, some types or batches of transport media are especially slow flowing.Please ensure one of the supported transport media listed in the package insert is being used, and that the lot in use is not unusually viscous.Some customers have found that switching lots or types of transport media resolves problems with streaking.Second samples ¿ the concentration of antigen in duplicate specimens collected from the same patient may vary.Therefore, corresponding confirmation results can also vary.Specimen quality ¿ specimen that contains particulates, mucous, or any other substance that increases viscosity, streaking and/or slow flow can give a false positive result.When possible, we recommend collecting specimens that minimize the amount of mucous.And with specimens that contain mucous, please seek to avoid using the viscous part of the specimen.Please note that the sensitivity of the test is not improved by including mucous in the specimen.Temperature of materials ¿ if samples, kit materials, or any transport media have been stored at temperatures below 15-30 degrees celsius, please allow at least 20 minutes for them to equilibrate to room temperature.Colder liquids flow more slowly, and can cause flow issues on the test device, which could lead to false positives.Environmental conditions ¿ warm temperatures and/or dry air can cause the liquid in the test device to evaporate quickly and dry out before flow is complete.Overly cold temperatures can increase liquid viscosity and humidity might be lower in the winter when heaters are in use.Please examine your testing environment for temperature and humidity conditions that could impact flow, and consider adjusting them if possible, while following the package insert.Air flow ¿ regardless of temperature or humidity, if air flow is strong in the testing environment, the liquid in the test device can dry quickly, impeding flow.If it¿s necessary to perform tests in a biosafety hood, fume hood, near air vents, near equipment fans, or in other conditions with strong air flow, devices should be protected.Some customers have found improved flow when they incubate the device in a protected area or under a protective cover, or if they reinsert the device into the foil sleeve during incubation.Please keep in mind that the following instructions are particularly important for avoiding problems that can lead to false positive tests: please ensure that the specimen is thoroughly mixed into the processing reagent prior to dispensing into the test devices.Ensure that you transfer no fewer than three (3) drops of the processed sample into the sample well of the test device.Ensure that the test device is on a level surface during incubation.Allow the test to run for the full 10 minutes before inserting it into the veritor reader or veritor plus analyzer (if using analyze now mode) please remember that the bd veritor flu a+b tests are not intended for screening purposes and are recommended only for diagnosing patients who exhibit influenza symptoms.Based on the results of this investigation, we were unable to replicate the conditions of the complaint.To conduct further investigation and testing on this issue, we would require access to clinical specimens and/or pcr test results (if available).Bd quality will continue to closely monitor for trends associated with false positive results as they relate to our rapid flow devices.Investigation conclusion: based on the results of this investigation, we were unable to replicate the conditions of the complaint.Root cause: unknown.Possible root causes can be correlated to a specimen specific issue, variability of second sample antigen concentration, or environmental factors.

Event Description

It was reported that a patient obtained a positive result from a bd veritor¿ system for rapid detection of flu a+b, 30 tests for flu a/b.Medical intervention was required.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS
• Type of Device: FLU LAB KIT
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9505632
• MDR Text Key: 182180023
• Report Number: 3006948883-2019-01116
• 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: EXEMPT
• 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
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: 256041
• Device Lot Number: 8326716
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention