MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Model Number 256041

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9315091, medical device expiration date: 2022-09-02, device manufacture date: 2019-11-11.Medical device lot #: 9361700, medical device expiration date: 2022-11-27, device manufacture date: 2019-12-27.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing with bd veritor¿ system for rapid detection of flu a + b laboratory kit 36 false positive results were obtained on mostly asymptomatic patients.Comparison testing via molecular rna influenza on same specimens were used.There was no report of patient impact.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval no.D10: returned to manufacturer on: 2021-01-20.H6: investigation summary this statement summarizes the investigation results regarding your complaint that alleges false positive results when using kit flu a + b 30 test hospital veritor (material # 256041), batch numbers 9315091, 9361700.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 and testing were performed on the batch number provided and no issue was found.The complaint was unable to be confirmed via the retain samples.The complaint sample was returned to bd as noted in tracking number (b)(4).Bd quality was unable to locate the returned sample as noted.The root cause could not be identified.A trend analysis for false positive results was conducted, no adverse trend was identified.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It was reported while testing with bd veritor¿ system for rapid detection of flu a + b laboratory kit 36 false positive results were obtained on mostly asymptomatic patients.Comparison testing via molecular rna influenza on same specimens were used.There was no report of patient impact.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11281796
• MDR Text Key: 232514167
• Report Number: 3006948883-2021-00187
• 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: K160164
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No
• 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