MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number 256056

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 with bd veritor(tm) system for rapid detection of flu a+b 3 false positive results were obtained.Confirmation testing was not performed.Results were reported as negative as results were not considered accurate given patient status.

Event Description

It was reported while testing with bd veritor(tm) system for rapid detection of flu a+b 3 false positive results were obtained.Confirmation testing was not performed.Results were reported as negative as results were not considered accurate given patient status.

Manufacturer Narrative

H.6.Investigation: the complaint was created for software issues on the bd veritor plus analyzer (p/n 256056, s/n (b)(6).The customer reported the analyzer gave false positive 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.See h.10.

• Brand Name: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11372783
• MDR Text Key: 242244675
• Report Number: 1119779-2021-00377
• Device Sequence Number: 1
• Product Code: PSZ
• Combination Product (y/n): N
• PMA/PMN Number: K112277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 256056
• Device Lot Number: JB202101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1