MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX PANEL NMIC-306; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449292

Device Problem False Positive Result (1227)

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

Event Date 08/01/2022

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.

Event Description

It was reported the while using bd phoenix panel nmic-306 a false positive cpo was found.The following information was provided by the initial reporter: customer problem: false positive cpo.Steps taken with customer/troubleshooting: customer had an isolate that was called cpo, but the ast results did not support this.Customer performed cepheid carba-r, and it was negative.Customer will repeat panel.Requested lot number, ae information, facility address, and instrument serial number.

Manufacturer Narrative

H.6 investigation summary: this complaint is not confirmed.This complaint is for false positive cpo failures when using phoenix panel nmic-306 (449292) batch number unknown.The customer did not provide panel returns, isolates or lab reports for the investigation.A review of quality notifications could not be performed since a batch number was not provided.A review of complaints could not be performed since a batch number was not provided.Complaint trending was performed and no trends were identified associated with this defect.Based on the overall investigation performed, this complaint is unable to be confirmed for a panel issue.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Per baltrmphxidastaph rev 10 version h, id 9.0-9.13, indicates the potential risk of false positive esbl, imlsb, beta lactamase and cpo including ambler classification as an s3.

Event Description

It was reported the while using bd phoenix panel nmic-306 a false positive cpo was found.The following information was provided by the initial reporter: customer problem: false positive cpo.Steps taken with customer/troubleshooting: customer had an isolate that was called cpo, but the ast results did not support this.Customer performed cepheid carba-r, and it was negative.Customer will repeat panel.Requested lot number, ae information, facility address, and instrument serial number.

• Brand Name: BD PHOENIX PANEL NMIC-306
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15171823
• MDR Text Key: 304818761
• Report Number: 1119779-2022-01074
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904492922
• UDI-Public: 382904492922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449292
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1