MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX NMIC-304; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT

Model Number	448486
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional 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 #: 0210495.Medical device expiration date: 2021-08-31.Device manufacture date: 2020-07-28.Medical device lot #: 0245325.Medical device expiration date: 2021-09-30.Device manufacture date: 2020-09-01.Medical device lot #: 0282502.Medical device expiration date: 2021-10-31.Device manufacture date: 2020-10-08.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that while testing with bd phoenix¿ nmic-304 there was false resistance.
Event or Problem Description
It was reported that while testing with bd phoenix¿ nmic-304 there was false resistance.
Additional Manufacturer Narrative
This complaint is for false resistant carbapenem results when using phoenix panel nmic 304 (448486) batches 0210495, 0245325 and 0282502.The customer provided lab report results, binary files and isolate returns for investigation.Five retention panels from a separate batch of this panel type nmic 304 (448486) were used to test each of the five isolates provided by the customer.Ertapenem (etp) was tested with escherichia coli 1598m.Imipenem (ipm) was tested with escherichia coli 0168m.Imipenem (ipm) was tested with escherichia coli 108m.Ertapenem (etp) was tested with proteus mirabilis 2348m.Ertapenem (etp) was tested with escherichia coli 0013m.The five panels yielded sensitive results per the package insert.Two retention panels from complaint batch 0282502 were used to test ertapenem (etp) using clinical isolate escherichia coli 1598m, where both yielded sensitive results per the package insert.Two retention panels from complaint batch 0245325 were used to test ertapenem (etp) using clinical isolate escherichia coli 0013m, where both yielded sensitive results per the package insert.Eight retention panels from complaint batch 0210495 were used.Imipenem (ipm) was tested with escherichia coli 0168m.Imipenem (ipm) was tested with escherichia coli 108m.Ertapenem (etp) was tested with proteus mirabilis 2348m.Ertapenem (etp) was tested with escherichia coli 0013m.All panels yielded sensitive results per the package insert.This complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on any of the three complaint batches.A review of complaints revealed no complaints generated on any of the three complaint batches.Complaint trending was performed and no trends were identified for this defect.Bd id/ast plant quality will continue to monitor for trends associated with this defect and take action as necessary.

• Brand Name: BD PHOENIX NMIC-304
• Common Device Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11333244
• Report Number: 1119779-2021-00305
• Device Sequence Number: 19120374
• Product Code: LON
• UDI-Device Identifier: 30382904484867
• UDI-Public: 30382904484867
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K032299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 09/30/2021
• Device Model Number: 448486
• Device Catalogue Number: 448486
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1