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 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Pma / 510k#: k111860, k130470.

Event Description

It was reported that bd max¿ system, bd max¿ instrument false negatives occurred.The following information was provided by the initial reporter: "a report of two specimens with false negatives, one for candida species one for bacterial vaginosis.They only use the instrument for vaginal panel.This customer receives the specimens in eswab tubes.They use an off-label sample processing, they add 200 l of eswab into sbt.They are using this protocol since the very beginning.The staff is the same.Do they always do confirmatory testing? if no, why now? they use bdmax as the primary test.If needed they plate the samples and then use conventional microbiological id testing (including maldi-tof).Do they always check the curves? if no, why now? yes, they always check the curves.Was it obvious that the results were erroneous/could not be trusted? some of the curves did not look fine, so they supposed some kind of problems.Were patient samples involved? yes.Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.If yes, was there any negative impact to the patient? ".

Manufacturer Narrative

H.6 investigation summary: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had "false negatives".Customer reported that they saw two suspected false negative results while running the mvp assay.It was reported that the customer uses conventional microbiological confirmatory testing and that they are using an off-label sample processing protocol for this assay.This complaint is unconfirmed as the issue alludes to a sample preparation and assay limit of detection issue.No problems were identified with instrument performance by service.The root cause cannot be determined with the information provided.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Review of device history record for instrument (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument (b)(6), and no additional work orders were observed 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 bd max¿ system, bd max¿ instrument false negatives occurred.The following information was provided by the initial reporter: "a report of two specimens with false negatives, one for candida species one for bacterial vaginosis.They only use the instrument for vaginal panel.This customer receives the specimens in eswab tubes.They use an off-label sample processing, they add 200 ¿l of eswab into sbt.They are using this protocol since the very beginning.The staff is the same.- do they always do confirmatory testing? if no, why now? they use bdmax as the primary test.If needed they plate the samples and then use conventional microbiological id testing (including maldi-tof).- do they always check the curves? if no, why now? yes, they always check the curves.- was it obvious that the results were erroneous/could not be trusted? some of the curves did not look fine, so they supposed some kind of problems.- were patient samples involved? yes.- were erroneous results reported to the clinician? no.- were patients treated based on erroneous results? no.- if yes, was there any negative impact to the patient? ".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15788832
• MDR Text Key: 307598435
• Report Number: 1119779-2022-01383
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/07/2023

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 Model Number: 441916
• Device Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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