MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256066

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

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd veritor plus analyzer false negative results were obtained by the laboratory personnel.The test cartridge was reinserted into another analyzer and the result was positive.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer reported that their veritor analyzer would give negative results for test cartridges that have a clear, visible line.She said that when the test cartridges were reinserted on the same analyzer, it gave out positive results.She also said that they have inserted the same test cartridges on other analyzers that they have and they came out positive.".

Event Description

It was reported that while using bd veritor plus analyzer false negative results were obtained by the laboratory personnel.The test cartridge was reinserted into another analyzer and the result was positive.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer reported that their veritor analyzer would give negative results for test cartridges that have a clear, visible line.She said that when the test cartridges were reinserted on the same analyzer, it gave out positive results.She also said that they have inserted the same test cartridges on other analyzers that they have and they came out positive.".

Manufacturer Narrative

Investigation: the complaint was created for results issues on the bd veritor plus analyzer (p/n 256066, s/n (b)(6)).The customer reported the analyzer is giving out false negative results.The device history record for bd veritor plus analyzer , sn (b)(6) , was examined and showed no discrepancies relate to this issue that can be correlated to this complaint.The reader passed all tests including the final assembly process, oqa, source inspection, functionality, and final packing test and manual inspection.The veritor plus analyzer , sn (b)(6) , was not returned for investigation and hence the root cause was unable to be determined.Therefore, complaint is not confirmed.Bd quality will continue to monitor for trends related to the veritor system.H3 other text : see h.10.

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 12005879
• MDR Text Key: 269585135
• Report Number: 1119779-2021-01001
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• PMA/PMN Number: K180438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

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 Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/05/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1