MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD PHOENIX NMIC-402; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 448874

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 01/18/2020

Event Type  Death  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

On march 2, 2020 the customer reported a false sensitive result with the bd phoenix¿ nmic-402 panel.A panel was setup on (b)(6) 2020 from a swab of the patient¿s leg wound.The patient¿s leg was amputated on (b)(6) 2020 when the result came back for enterobacter cloacae; sensitive for amikacin.The clinician immediately started treatment with amikacin on (b)(6) 2020 to (b)(6) 2020 and sample was sent to (b)(6) center.On (b)(6) 2020 the result came back; enterobacter cloacae, resistant for amikacin.The patient died on (b)(6) 2020 but it is unclear if the patient died due to the incorrect treatment or general condition of patient due to severity of other diseases when he came into the hospital.

Manufacturer Narrative

B.1.Changed adverse type to reported issue is both an adverse event and product problem.H.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Complaint verbatim states: "arteriosclerosis of extremities, chronic pulmonary insufficiency following surgery.He died of other causes than antibiotic therapy.Leg amputation in which the above case of enterobacter cloacae was found in a swab from a wound.Bdphoenix result: enterobacter cloacae kpc ¿ ; mbl+ ; resistant strain after this information the amputation decision was made" h3 other text : see h.10.

Event Description

On (b)(6) 2020 the customer reported a false sensitive result with the bd phoenix¿ nmic-402 panel.A panel was setup on (b)(6) 2020 from a swab of the patient¿s leg wound.The patient¿s leg was amputated on (b)(6) 2020 when the result came back for enterobacter cloacae; sensitive for amikacin.The clinician immediately started treatment with amikacin on (b)(6) 2020 and sample was sent to the national reference center.On (b)(6) 2020 the result came back; enterobacter cloacae, resistant for amikacin.The patient died on (b)(6) 2020 but it is unclear if the patient died due to the incorrect treatment or general condition of patient due to severity of other diseases when he came into the hospital.

Event Description

On (b)(6) 2020 the customer reported a false sensitive result with the bd phoenix¿ nmic-402 panel.A panel was setup on (b)(6) 2020 from a swab of the patient¿s leg wound.The patient¿s leg was amputated on (b)(6) 2020 when the result came back for enterobacter cloacae; sensitive for amikacin.The clinician immediately started treatment with amikacin on (b)(6) 2020 to (b)(6) 2020 and sample was sent to the national reference center.On (b)(6) 2020 the result came back; enterobacter cloacae, resistant for amikacin.The patient died on (b)(6) 2020 but it is unclear if the patient died due to the incorrect treatment or general condition of patient due to severity of other diseases when he came into the hospital.

Manufacturer Narrative

H.6.Investigation summary: this complaint is for false susceptible amikacin results with enterobacter cloacae when using phoenix panel nmic 402 (448874) batch 9260974.The customer provided their confirmatory testing results but no product returns or isolates were provided.Retention panels from the complaint batch and control panels of a separate lot were tested with in-house isolates of e.Cloacae and loaded into a phoenix m50 instrument.The amikacin mic results for all isolates were expected to be >16, resistant.All replicates, for both the complaint lot and control lot yielded an mic result of >16, resistant.This complaint is not confirmed.A review of quality notifications revealed no quality notifications noted on the complaint batch for this defect.The frequency of this complaint has been assessed and has been determined to fall below the threshold level of an actionable trend.Bd id/ast will continue to monitor all complaints and take appropriate action should the level exceed required thresholds.It is important to note the following: bd xpert system is developed based on published information through standard organizations and current scientific literature.This system is designed to assist the clinician in the selection of appropriate drug therapy; however, it is not designed to replace the clinician¿s expertise in the treatment of patients.Patient¿s medical history, response to therapy, as well as other clinical indications must be utilized in combination with laboratory reporting to determine treatment.Eucast annually publishes updates to their standards, which should be reviewed with laboratory personnel, clinicians, and infectious disease consultation.The bdxpert system is updated periodically in response to these publications, however, users can customize any breakpoint based on institutional practice or newly acquired information.The current bdxpert pud 6.61a is reflective of eucast version 9.0 enterobacterales table.In this table, an mic of 16 for amikacin would be interpreted as intermediate and considered a high dose only agent and has the comment ¿most often aminoglycosides are given in combination with beta-lactam agents¿.This language, specifically the use of ¿most often¿, indicates this is for informational use.This criterion did not warrant a bdxpert rule for 2019 due to the informational status.However, this language has been changed in eucast version 10.0 to ¿for systemic infections, aminoglycosides must be used in combination with other active therapy¿.The amikacin breakpoints have also changed and an mic of 16 is now considered resistant.The harsher language usage of ¿must be¿ is more definitive, which indicates a bdxpert rule will be created, in addition to the breakpoints being updated (if possible on current panel formats) during the 2020 eucast update.

• Brand Name: BD PHOENIX NMIC-402
• Type of Device: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 9874701
• MDR Text Key: 184757962
• Report Number: 1119779-2020-00011
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 448874
• Device Lot Number: 9260974
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death