MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256082

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 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Eua # (b)(4).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 for sars-cov-2 discrepant results were obtained.A negative result was obtained on the veritor, customer visually noticed 3 lines.Retest performed with remaining reagent and result was positive.Additional confirmatory testing not performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # (b)(4).

Event Description

It was reported while testing for sars-cov-2 discrepant results were obtained.A negative result was obtained on the veritor, customer visually noticed 3 lines.Retest performed with remaining reagent and result was positive.Additional confirmatory testing not performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # (b)(4).

Manufacturer Narrative

H6: investigation summary this statement summarizes the investigation results regarding your complaint that alleges false negative or discrepant results when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number 0285008.Bd quality performs a systematic approach to investigate false negative or 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 and testing were performed on the batch number provided and no relevant issue was found.The reported issue was unable to be confirmed via retain samples.The root cause could not be identified.A trend analysis for false negative or discrepant results was conducted, no adverse trend was identified.There were no corrective actions taken at this time.H3 other text : see h10.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: 11286328
• MDR Text Key: 230744481
• Report Number: 3006948883-2021-00194
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0285008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2020
• 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