MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) KIT FLU A+B 30 TEST PHYSICIAN VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Model Number 256045

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 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using kit flu a+b 30 test physician veritor 3 possible false positive results were obtained by the laboratory personnel.A false positive may lead to treatment with a less tolerated antibiotic which can lead to serious adverse patient consequence.A biofire rpp was used to confirm 2 of the results as false positives.There was no report of patient impact.

Manufacturer Narrative

H6: investigation summary bd point of care quality initiated investigation on the customer report regarding alleged false positive when using the kit flu a+b 30 test physician veritor (ref# (b)(4)).Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.There was no lot number documented in the submission of this complaint; therefore no internal investigations can be performed and the issue cannot be confirmed.No returns were received to investigate.The investigation did not find a root cause for the false positive results reported.In a follow-up, customer indicated that the issue was resolved by vortexing the specimen and running the specimen without delay.Bd cannot confirm the complaint based on the investigation that was performed.Bd point of care will continue to closely monitor for trends associated with false positive when using the kit flu a+b 30 test physician veritor (ref# (b)(4)).There was no corrective action taken at this time.

Event Description

It was reported that while using kit flu a+b 30 test physician veritor 3 possible false positive results were obtained by the laboratory personnel.A false positive may lead to treatment with a less tolerated antibiotic which can lead to serious adverse patient consequence.A biofire rpp was used to confirm 2 of the results as false positives.There was no report of patient impact.

• Brand Name: KIT FLU A+B 30 TEST PHYSICIAN VERITOR
• 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: 11248123
• MDR Text Key: 232260242
• Report Number: 1119779-2021-00169
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• PMA/PMN Number: K132692
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1