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

Model Number 441916

Device Problem False Negative Result (1225)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

G.5.Pma/510(k)#: k111860, k130470.H.3.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 with use of bd max¿ system, bd max¿ instrument there were false negatives.Exact occurrences are not specified.Results were not reported.There was no patient impact.The following information was provided by the initial reporter: "we have found that the sensitivity of salmonella detection has dropped since we first started using max and is currently around 7% false negative.".

Event Description

It was reported that with use of bd max¿ system, bd max¿ instrument there were false negatives.Exact occurrences are not specified.Results were not reported.There was no patient impact.The following information was provided by the initial reporter: "we have found that the sensitivity of salmonella detection has dropped since we first started using max and is currently around 7% false negative.".

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had "false negatives".The customer reached out to bd reporting that the sensitivity of salmonella detection has dropped since they first started using the machine and is currently around 7% false negative.They are also noticing specificity issues of the stx, with almost 20% of stx detected on the bd max having no stx detected at the reference laboratory.Bd requested customer data, however the data provided to bd was from december 2022 and due to age bd is unable to discern whether the issues are instrument or reagent related.No further data was received from the customer.The instrument went through preventative maintenance in april 2023 and is performing within specifications.Due to lack of more information, bd is unable to determine the root cause, and the case has been closed as an unconfirmed failure.Hr review is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Samples in the form of customer files were provided to bd, however the files were too old and no root cause determination was able to be determined.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17187177
• MDR Text Key: 317998061
• Report Number: 1119779-2023-00692
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H.10
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441916
• Device Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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