MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; NOT CLASSIFIED

Catalog Number 256088

Device Problem False Positive Result (1227)

Patient Problem Diarrhea (1811)

Event Date 09/11/2021

Event Type  Injury  

Manufacturer Narrative

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 while testing with bd veritor ¿ sars-cov-2 & flu a+b, 4 false positive results were obtained.Confirmatory testing was performed using pcr test method and the result was negative.The false positive results led to the patient receiving unspecified medical intervention with the only mentioned effect to the patient being diarrhea.There was no indication that results were reported.Eua# (b)(4).The following information was provided by the initial reporter: customer reports four fps with 256088, lot #1189936.A confirmation test via pcr and a competitor, quidel quikview flu a/b was performed after erroneous results were obtained.Was there patient impact as a result of the false result? yes.If yes, were results reported to a medical doctor? yes.If yes, did the patient receive treatment? yes.If yes, any adverse effect on the patient? diarrhea.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges false positive results when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch number 1189936.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.The reported was unable to be confirmed.The root cause could not be identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that while testing with bd veritor ¿ sars-cov-2 & flu a+b, 4 false positive results were obtained.Confirmatory testing was performed using pcr test method and the result was negative.The false positive results led to the patient receiving unspecified medical intervention with the only mentioned effect to the patient being diarrhea.There was no indication that results were reported.Eua# (b)(4).The following information was provided by the initial reporter: customer reports four fps with 256088, lot #1189936.A confirmation test via pcr and a competitor, quidel quikview flu a/b was performed after erroneous results were obtained.Was there patient impact as a result of the false result? yes.If yes, were results reported to a medical doctor? yes.If yes, did the patient receive treatment? yes.If yes, any adverse effect on the patient? diarrhea.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: NOT CLASSIFIED
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12640398
• MDR Text Key: 276947134
• Report Number: 3006948883-2021-00973
• Device Sequence Number: 1
• Product Code: QMN
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 256088
• Device Lot Number: 1189936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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): Required Intervention