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 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

(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 a discrepant result was obtained.Visually the customer reported 2 lines above and below the "t" on device and analyzer shows negative.Confirmatory testing was not performed.There was no report of patient impact.(b)(4).

Event Description

It was reported while testing for sars cov-2 a discrepant result was obtained.Visually the customer reported 2 lines above and below the "t" on device and analyzer shows negative.Confirmatory testing was not performed.There was no report of patient impact.Eua # (b)(4).

Manufacturer Narrative

H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges invalid result results when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number 0328057.Bd quality performs a systematic approach to investigate invalid result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.A batch review was performed for the number provided.The reported issue was unable to be confirmed.The retention testing could not be tested as they are expired.Returned product testing could not be completed a samples are expired.There are no current trends against invalid results.However, the returned photographic evidence provided confirms the customer's report of invalid results.Bd quality will continue to closely monitor for trends.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: 11368795
• MDR Text Key: 234082099
• Report Number: 3006948883-2021-00252
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/17/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0328057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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