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

Model Number 449289

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

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Report 3 of 6 it was reported that panel phoenix nmic/id-307 misidentification has occurred.The following information was provided by the initial reporter: customer is reporting mis id.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: this complaint is not confirmed.This complaint is for misidentification of escherichia coli as citrobacter freundii and shigella when using phoenix panel nmic/id-307 (449289) batch numbers 1021658, 2110796 and 2229685.Panel batch 2229685 was unavailable and a comparable batch (2235337) of the same material was used.Batch 1021658 was expired at the time of investigation and not used in complaint testing.The customer did not return panels or phoenix generated lab reports but provided isolates for the investigation.Each of the four (4) customer returned isolates were labeled as fl-2, fl-7, fl-8, and fl-10.To investigate, each of customer returned isolates fl-2, fl-7, fl-8, fl-10 were ran on a bruker maldi for identification results.All four (4) isolates were identified as e.Coli on the bruker maldi.Then each of the four (4) customer returned isolates were tested on a phoenix m50 with retention panels from complaint batch 2110796 and retention panels from the same material but a different batch number and evaluated for identification results.During investigation testing, all panels tested yielded satisfactory identification results.Therefore, this complaint is not confirmed.The difficulty in differentiating between shigella species and escherichia coli, both closely-related members of the enterobacterales group, is widely known.Although these species are phenotypically very similar, they are epidemiologically different in their presentation of clinical disease.Because of this, many clinical laboratories will incorporate guidance in their standard operating procedures for ruling out misidentification of shigella species and e.Coli by common identification systems by checking colony morphology and indole and motility reactions.If, after assessment of all available information, a clinical lab is unable to confidently report an identification between these two species, the isolate may be sent to a reference laboratory for definitive identification a review of quality notifications revealed no quality notifications generated on either of the complaint batches 1021658, 2110796 and 2229685.A review of complaints revealed no additional complaints on batch 2110796 and 1021658.A review of complaints revealed two (2) additional complaints on batch 2229685, both of which are unconfirmed and one (1) of which is related to this defect.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.Please continue to communicate any additional concerns.H3 other text : see h.10.

Event Description

It was reported that panel phoenix nmic/id-307 misidentification has occurred.The following information was provided by the initial reporter: customer is reporting mis id.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16229497
• MDR Text Key: 308084191
• Report Number: 1119779-2023-00061
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904492893
• UDI-Public: 30382904492893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181665
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 449289
• Device Catalogue Number: 449289
• Device Lot Number: 2229685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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