MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Catalog Number 441916

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

E.6 initial reporter e-mail: (b)(6).G6 pma / 510(k)#: k111860, k130470.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument that there was fasle negative results.The following information was provided by the initial reporter: 441916 - instrument max clinical ct2387.User suspect a false negative result with bd max for a patient sample with a user developed protocol (histoplasma).This patient is suspected to be positive from a clinical point of view.False negative results suspected.Nice amplification curve in raw data, but no curve after normalization.Instrument issue suspected, for a user develop protocol (not for bd reagent).

Manufacturer Narrative

Investigation summary: the complaint alleges the bd max instrument had "false negatives." customer reported that they are witnessing suspected false negative results for histoplasma while running their udp (user-defined protocol) assay.The customer instrument database was provided to bd service and quality for analysis which did not reveal any evidence of instrument issue.Analysis of the instrument database shows that instrument performance is within bd specifications.This complaint is unconfirmed as no problem was identified with instrument performance.The root cause of the issue cannot be determined with the information provided.Sample analysis consisted of customer instrument run data files.Analysis by bd quality did not reveal any evidence of an instrument performance issue.Review of the device history record for the instrument is not required because the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument and two additional cases were observed on (b)(6) 2023 for the complaint failure mode reported.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument that there was fasle negative results.The following information was provided by the initial reporter: 441916 - instrument max clinical ct2387 user suspect a false negative result with bd max for a patient sample with a user developed protocol (histoplasma).This patient is suspected to be positive from a clinical point of view.False negative results suspected.Nice amplification curve in raw data, but no curve after normalization.Instrument issue suspected, for a user develop protocol (not for bd reagent).

• Brand Name: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
• Type of Device: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17620788
• MDR Text Key: 321937864
• Report Number: 1119779-2023-00940
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: FG
• PMA/PMN Number: K111860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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
• Device Operator: Other
• Device Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• 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