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 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that panel phoenix nmic/id-307 misidentification occurred.The following information was provided by the initial reporter: customer reported misidentification of organism using the nmicid307.Lot#2242666 hazard, injury or erroneous results? no; hazard, injury or erroneous results details.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01482 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

Event Description

It was reported that panel phoenix (b)(6) misidentification occurred.The following information was provided by the initial reporter: customer reported misidentification of organism using the (b)(6).Lot#2242666 hazard, injury or erroneous results? no hazard, injury or erroneous results details.

• 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: 15973095
• MDR Text Key: 306900521
• Report Number: 1119779-2022-01482
• Device Sequence Number: 1
• Product Code: LON
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 449289
• Device Catalogue Number: 449289
• Device Lot Number: 2242666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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