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

Catalog Number 449292

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

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

Event Date 11/30/2021

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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1293688, medical device expiration date: 2022-10-31, device manufacture date: 2021-10-20; medical device lot #: 1299259; medical device expiration date: 2022-11-30; device manufacture date: 2021-10-26.

Event Description

It was reported that while using bd panel phoenix nmic-306 false resistance were observed by the laboratory personnel.A etest was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following fields were corrected with additional information: "it was reported that panels are overcalling ertapenem resistance in the enterobacterales.".

Manufacturer Narrative

H.6 investigation summary: this complaint is for false positives reported when using panel phoenix nmic-306 (449292) batch number 1293688 and 1299259.The customer did not provide lab reports, panels or isolate returns for investigation.To investigate, 5 panels from batch 1293688 and 1299259 and control were tested against were tested with escherichia coli (atcc 25922) for the following drugs: ertapenem (etp) all results met the expected results.A review of quality notifications revealed no quality notifications for this complaint batch.A review of complaints revealed two additional complaints for this complaint batch.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that while using bd panel phoenix nmic-306 false resistance were observed by the laboratory personnel.A etest was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following fields were corrected with additional information: "it was reported that panels are overcalling ertapenem resistance in the enterobacterales.".

• Brand Name: BD PANEL PHOENIX 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: 13084540
• MDR Text Key: 286373518
• Report Number: 1119779-2021-02035
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151320
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449292
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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