MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX NMIC-311; SYSTEM, TEST, AUTO ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 449452

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0231101.Medical device expiration date: 2021-08-31.Device manufacture date: 2020-08-18.Medical device lot #: 0273231.Medical device expiration date: 2021-10-31.Device manufacture date: 2020-09-29.Numerous drugs were reported to be involved, however, we were not able to obtain which ones, therefore 510k information is not available.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 while using bd phoenix¿ nmic-311 patterns do not match phenotype with many of the antibiotics.Purity plates are not contraminated and after repeat appear normal.The following information was provided by the initial reporter: it was reported that discrepant results with nmic-311.All growth was confirmed by maldi as acinetobacter lwoffii.Mic patterns do not match phenotype across a number of antibiotics, purity plates are not contaminated and after repeat results look normal.

Event Description

It was reported while using bd phoenix¿ nmic-311 patterns do not match phenotype with many of the antibiotics.Purity plates are not contaminated and after repeat appear normal.The following information was provided by the initial reporter: it was reported that discrepant results with nmic-311.All growth was confirmed by maldi as acinetobacter lwoffii.Mic patterns do not match phenotype across a number of antibiotics, purity plates are not contaminated and after repeat results look normal.

Manufacturer Narrative

Investigation summary: this complaint is for discrepant mic results when using phoenix panel nmic-311 (449452) batch numbers 0231101, 0273231, and 0294469.The customer did provide lab reports and isolate returns for investigation.  customer submitted isolates, reporting questionably resistant or intermediate results when initially tested and susceptible results upon subsequent repeat testing.To investigate, a total of twenty six (26) retention panels from the complaint batches were tested using a phoenix m50 instrument using the returned isolates from the customer and evaluated for mic values.Two runs were performed to assess for any discrepancies in mic results.Two of the returned isolates gave a resistant or intermediate results on the first run during investigation.On the second run, these results were susceptible.A third run was performed for these isolates for verification using test panels from the complaint batches and control panels.Both panels yielded susceptible results for the third investigational run for one of the isolates (8994305), but isolate (8996438) tested susceptible for the retention panel tested, but resistant for the control panel.These isolates were tested by disk diffusion for the drugs in question.The disk diffusion results affirmed that both of these isolates yield results that are right on the breakpoint for the drugs in question.All other customer returned isolates tested during investigation did not yield discrepant results between runs; all runs matched the susceptible results observed by the customer on the second run at their lab.In summary, it would appear that the initial resistant or intermediate results obtained by the customer were falsely resistant/intermediate, most likely due to workflow issues.The customer¿s second run of the isolates, which yielded susceptible results, matched the findings in this internal investigation, except for the two isolates that have mics that fall on the breakpoint for the drugs in question.This complaint is not confirmed for discrepant results.

• Brand Name: BD PHOENIX NMIC-311
• Type of Device: SYSTEM, TEST, AUTO ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11665246
• MDR Text Key: 272315674
• Report Number: 1119779-2021-00662
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 449452
• Device Lot Number: 0294469
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1