MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC 203; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 448764

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using panel phoenix nmic 203 a misidentification was observed by the laboratory personnel.A disk diffusion test was used to confirm the result as discrepant.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation summary: this complaint is for discrepant imipenem results when using phoenix panel nmic 203 (448764) batch 0210475.Samples were not returned, but the lab result report was provided from the customer.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints showed that there were no confirmed complaints for this batch.Complaint trending revealed no trends associated with the associated complaints.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.The customer received a phoenix result of intermediate, however, confirmatory testing yielded a susceptible result.Per clsi, isolates with mics in the intermediate breakpoint range can potentially be treated with the drug if the appropriate levels of the drug can be attained in the blood/tissue, although the response rate of the drug may be lower than that of a drug with mics in the susceptible range.The intermediate breakpoint also acts a buffer zone for the inherent variability in test methods.For this event, phoenix called the imipenem intermediate (mic=2), while the ipm disk diffusion was susceptible.This is considered a minor error discrepancy.No isolates were provided by the customer for internal testing.Internal k.Pneumoniae (10997, 11001) isolates was tested with retention panels from the complaint type and yielded the expected results with an mic =1 for both panels.This complaint is not confirmed.

Event Description

It was reported that while using panel phoenix nmic 203 a misidentification was observed by the laboratory personnel.A disk diffusion test was used to confirm the result as discrepant.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: PANEL PHOENIX NMIC 203
• 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: 11325021
• MDR Text Key: 242461174
• Report Number: 1119779-2021-00301
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 448764
• Device Lot Number: 0210475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1