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

Catalog Number	449452
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k020322, k022129, k023444, k023634, k023858, k024153, k031530, k031699, k031912, k032299, k032567, k032655, k033362, k033560, k041384, k042932, k052269, k060214, k060217, k060257, k060444, k060447, k061327, k061355, k062207, k062944, k063301, k063486, k063573, k063811, k063824, k071623, k123404, k132674, k132909, k151320, k173252, k190905, k163637, k173523, k033458 and k123266.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 an unspecified number of patient isolates had high mics (false resistances) for carbapenems.The user noted that specific drugs like, ertapenem and meropenem, are resistant but are not with repeat testing.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes h.3 device eval by manufacturer? yes d9: returned to manufacturer on: 06-nov-2024 investigation summary this complaint is for false resistance to carbapenems when using phoenix panel nmic-311 (catalog number 449452) batch number 4233343.The customer provided panel returns, isolates and phoenix generated lab reports for the investigation.The lab reports show klebsiella pneumoniae and proteus mirabilis with varied carbapenem mics when using the complaint batch.To investigate, retention panels of complaint batch 4233343 were inoculated with customer returned isolates k.Pneumoniae d1, k.Pneumoniae d11, p.Mirabilis c1 and p.Mirabilis c2 and evaluated for carbapenem mic results.In addition, one control panel each from the same material but different batch were inoculated with customer returned isolates k.Pneumoniae d1, k.Pneumoniae d11, p.Mirabilis c1 and p.Mirabilis c2 and evaluated for carbapenem mic results.Last, customer returned panels of complaint batch 4233343 were inoculated with customer returned isolates k.Pneumoniae d1, k.Pneumoniae d11, p.Mirabilis c1 and p.Mirabilis c2 and evaluated for carbapenem mic results.All panels tested returned the expected mics for carbapenems, therefore, this complaint is not confirmed.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends associated with this defect.Please continue to communicate additional concerns.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 an unspecified number of patient isolates had high mics (false resistances) for carbapenems.The user noted that specific drugs like, ertapenem and meropenem, are resistant but are not with repeat testing.No health impact or consequence reported.

• Brand Name: BD PHOENIX¿ NMIC-311
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20745702
• Report Number: 1119779-2024-00914
• Device Sequence Number: 8483726
• Product Code: LON
• UDI-Device Identifier: 30382904494521
• UDI-Public: (01)30382904494521(11)240820(17)250814(10)4233343
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/14/2025
• Device Catalogue Number: 449452
• Device Lot Number: 4233343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown