MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256040

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that the kit grp a strep 30 test veritor gave false negative test results.Aerobic/anaerobic swab culture confirmatory testing was performed.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: customer alleges sample is false positive.What type of reference method was used to confirm the result (pcr, viral culture, etc)? -aerobic/anaerobic swab culture.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges false negative results when using kit grp a strep 30 test veritor (material # 256040), batch number 1123931.Bd quality performs a systematic approach to investigate false negative 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 issue was unable to be confirmed.No adverse trend against false negative results was identified.The root cause could not be identified.

Event Description

It was reported that the kit grp a strep 30 test veritor gave false negative test results.Aerobic/anaerobic swab culture confirmatory testing was performed.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: customer alleges sample is false positive.What type of reference method was used to confirm the result (pcr, viral culture, etc)? - aerobic/anaerobic swab culture.

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13654737
• MDR Text Key: 286595591
• Report Number: 3006948883-2022-00065
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122718
• 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: 06/15/2022

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: 07/13/2023
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 1123931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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