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 Positive Result (1227)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types.The information for each additional type is as follows: d.2.Medical device type: nqx, ooi, ozn.There were multiple pma/510k numbers: g.5.Pma / 510(k)#: k111860, k120138, k130470.H3.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 during use of the bd max¿ system, bd max¿ instrument, there was a mdr-tb false positive patient result.The pcr curve was unusual, so the test was repeated, and the result was mdr-tb negative.There was no report of patient impact.

Event Description

It was reported that during use of the bd max¿ system, bd max¿ instrument, there was a mdr-tb false positive patient result.The pcr curve was unusual, so the test was repeated, and the result was mdr-tb negative.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd max instrument had "false positives".Customer reported that they are witnessing suspected false positive results for the mdr-tb assay.The customer instrument run database was provided to bd service and quality for further analysis which did not reveal any trends indicating an instrument performance issue.A bd fse was dispatched to the customer site where they performed an instrument health check and did not identify any functional issues.An instrument preventative maintenance (pm) service was performed, and the instrument was successfully qualified for customer use.This complaint is unconfirmed as the issue was unable to be reproduced and the instrument was found to be operating within bd specifications.The root cause of the issue was unable to be determined with the information provided.Sample analysis consisted of the customer instrument database.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 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 and no additional cases 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.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19202724
• MDR Text Key: 341630796
• Report Number: 1119779-2024-00331
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00382904419165
• UDI-Public: (01)00382904419165
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: SEE H10
• 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: 06/21/2024

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: 04/09/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 06/21/2024
• Supplement Dates FDA Received: 07/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2018
• 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