MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC/ID-307; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449289

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

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

Event Type  malfunction  

Manufacturer Narrative

G5.The panel phoenix nmic/id-307 is a panel that consists of a combination of the following 510k numbers: k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320 h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with the panel phoenix nmic/id-307, a patient sample of e.Coli was misidentified as citrobacter farmeri.There was no report of patient impact.Report 2 of 4.

Event Description

It was reported that during use with the panel phoenix nmic/id-307, a patient sample of e.Coli was misidentified as citrobacter farmeri.There was no report of patient impact.Report 2 of 4.

Manufacturer Narrative

H.6.Investigation summary: this complaint is for misidentification of proteus mirabilis and escherichia coli as citrobacter species and providencia rettgeri when using phoenix panel nmic/id-307 (catalog number 449289) batch number 3241315.The customer returned panels, isolates and phoenix generated lab reports for the investigation.The customer provided phoenix lab reports show an isolate identified as p.Mirabilis, e.Coli, c.Farmeri, c.Freundii and p.Rettgeri when using the complaint batch.Isolate 33500361 was not a pure culture and not used in investigatin testing.The other four customer returned isolates were verified on a bruker maldi biotyper and labeled as p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12.To investigate, retention and customer returned panels from the complaint batch were tested using customer returned isolates p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12 on a phoenix m50 machine and evaluated for identification results.In addition, one control panel from the same material but different batch was tested using customer returned isolates p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12 on a phoenix m50 machine and evaluated for identification results.The twelve panels tested identified their inoculated isolate correctly, therefore, this complaint is not confirmed for misidentification.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed seven additional complaint on the complaint batch, four of which are related to this defect and unconfirmed.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Thank you again for contacting bd and please continue to communicate any further concerns.

• Brand Name: PANEL PHOENIX NMIC/ID-307
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18607710
• MDR Text Key: 334107585
• Report Number: 1119779-2024-00052
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904492892
• UDI-Public: (01)00382904492892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• 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: 05/08/2024

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 Catalogue Number: 449289
• Device Lot Number: 3241315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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