MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC 408; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 448877

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 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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).This product is not sold in the us.It may be similar to other product currently registered for sale in the us.Investigation is on going to determine which product is most similar.Additional information will be submitted upon completion of investigation.

Event Description

It was reported that while using panel phoenix nmic 408 atypical reactions were observed statistically.There was no indication that results were reported out and there was no report of patient impact.

Event Description

It was reported that while using panel phoenix nmic 408 atypical reactions were observed statistically.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation: the complaints are for false resistance of gentamicin (gm) and tobramycin (nn) with proteus mirabilis when using phoenix panel nmic-408 (448877) batch number 0273252 and unmic-409 (448804) batch numbers 0259265, 0274347, and 0267782.The customer did provide 12 returned isolates of proteus mirabilis and lab reports for investigation.To investigate, a total of two (2) retention panels from the complaint batch were tested by bd¿s qc department using the 12 customer returned isolates of proteus mirabilis with a phoenix 100 instrument and evaluated for gentamicin (gm) and tobramycin (nn).During investigation, all panels yielded a result of susceptible for both evaluated drugs.All panels yielded results of 2 for gentamicin (gm) and =1 for tobramycin (nn).These isolates were then sent to bd¿s r&d team for additional testing.The r&d team first confirmed all organism id¿s using the bruker maldi system.All 12 proteus mirabilis strains were tested once, in parallel, on phoenix m50 in nmic-500 lot #0148110 and bmd reference panel.10 of the 12 proteus mirabilis strains resulted in a resistant mic result on the m50, as compared to a susceptible mic result on bmd reference panel.All 12 strains were susceptible for nn with bmd; however, the phoenix panel nmic-500 does not contain nn, so comparison of nn could not be completed with the r&d team¿s testing.This complaint is confirmed.As a result of this testing, combined with additional customer complaints regarding gm false resistance, several variables with the current phoenix gm panel formulation and other associated consumable phoenix products were investigated.The investigational team has identified at least one variable that we may be able to modify to improve panel performance.The r&d team is currently in the process of writing a formal recommendation for this modification so that a change control may be opened and the change implemented.We appreciate your willingness to share isolates which have helped provide critical feedback during this investigation process.A review of quality notifications revealed no quality notifications for the complaint batch.A review of complaints revealed no additional complaints for the complaint batch.Complaint trending was performed and trend limits were breached associated with this defect.As always, the bd id/ast plant quality will continue to monitor for trends and take action as necessary.

• Brand Name: PANEL PHOENIX NMIC 408
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11349033
• MDR Text Key: 232602283
• Report Number: 1119779-2021-00329
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 448877
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1