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 10/05/2023

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ enteric bacterial panel, there was a false negative of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "max 442963_3137729 discrepant result for vibrio between (b)(6) this was a false negative as our stool culture grew vibrio".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.Site legal name (fda): becton, dickinson & co.(sparks) d1.Medical device brand name: bd max¿ system, bd max¿ instrument.D2a.Common device name: instrumentation for clinical multiplex test systems.D3.Medical device manufacturer: becton, dickinson & co.(sparks).D4.Medical device catalog #: 441916.D4.Medical device serial#: (b)(6).D4.Medical device expiration date: unknown.D4.Unique identifier (udi) #: (b)(4).G1: manufacturing location: becton, dickinson & co.(sparks).G5: pma/510(k)#: k111860, k130470.H4.Device manufacture date: 24-apr-2023.H5.Labeled for single use: no.H.6.Investigation summary: the complaint alleges the bd max instrument had "discrepant results." customer reported that they are witnessing discrepant results for vibrio while running the extended enteric bacterial panel assay.The customer run database was provided to bd service specialists and quality for further analysis.This analysis revealed reader normalization ratios which are out of specification.A bd field service (fse) was dispatched to the customer site where they performed re-normalization of both readers.Instrument performance was qualified following repair and was confirmed to be operational to bd specifications.This complaint is confirmed by service & quality.The root cause was traced to an operational failure of the readers due to a drift in the normalization ratios.Sample analysis consisted of customer instrument run data files.Analysis by bd quality revealed normalization ratios not in specification for the readers.Dhr 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.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.

Event Description

It was reported that while using bd max¿ enteric bacterial panel, there was a false negative of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "max 442963_3137729 discrepant result for vibrio between ct3205 and ct3216 this was a false negative as our stool culture grew vibrio".

• 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: 18030577
• MDR Text Key: 326862510
• Report Number: 3007420875-2023-00100
• Device Sequence Number: 1
• Product Code: OOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 441916
• Device Lot Number: 3137729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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