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 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

G.5.Pma / 510(k)#: 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 while using bd max¿ system, bd max¿ instrument, customer received three false negative results.No patient impact reported.The following information was provided by the initial reporter: "customer complains that the data obtained are not reproducible on other instruments of molecular biology like cepheid and in three cases seems that they have obtained false negatives on bdmax instrument.".

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument, customer received three false negative results.No patient impact reported.The following information was provided by the initial reporter: "customer complains that the data obtained are not reproducible on other instruments of molecular biology like cepheid and in three cases seems that they have obtained false negatives on bdmax instrument.".

Manufacturer Narrative

H.6 investigation summary: the complaint alleges the bd max instrument had "false negatives." customer reported that they are witnessing suspected false negative results while running the cpo assay.The customer instrument run files and database were provided to bd service and quality for further analysis.This analysis revealed evidence of environmental contamination.There was no evidence of any instrument-related functional issues.Bd service specialists instructed the customer to clean the instrument per the bd max decontamination protocol.This complaint is unconfirmed as the instrument was confirmed to be functioning within specifications.The root cause of the issue was contributed to environmental contamination which caused saturation of the optical signal.Sample analysis consisted of customer instrument run data files.Analysis by bd quality revealed evidence of environmental contamination and saturation of the optical signal.Review of device history record for this 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17484024
• MDR Text Key: 320883486
• Report Number: 1119779-2023-00858
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/19/2023

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: 07/24/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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