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 06/22/2023

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument, there was a false negative on a patient sample.No patient impact reported.The following information was provided by the initial reporter: "bd max technique does not detect yersinia customer calls into question the result because bacteria from the samples concerned grow on a petri dish with a large number of colonies (50 cfu).It was a patient sample.".

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.

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had a "false negative" result.Customer reported receiving that their instrument is not detecting yersinia.The customer question as the bacteria from their sample was grown on a petri dish.Application specialist determined that there were no technical issue with the instrument.The instrument has received a change in gantry, drawer realignment, reinstallation of the os of the aio, and realignment.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or a failure at install.Device was installed on 27sep2019, and since then other service activities have occurred, such as preventative maintenance and repair, which have changed the configuration of the instrument since release from manufacturing.Service history review was performed for the instrument (b)(6) and no additional work order was observed for the complaint failure mode reported.No samples were returned for investigation, therefore returned sample analysis was not performed.Root cause cannot be determined with the information provided.Complaint is unconfirmed by application specialist.Review of risk management files confirms there are no new, modified, or additional risks associated with this failure mode.Bd quality will continue to monitor trends associated with this failure mode.

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument, there was a false negative on a patient sample.No patient impact reported.The following information was provided by the initial reporter: "bd max technique does not detect yersinia.Customer calls into question the result because bacteria from the samples concerned grow on a petri dish with a large number of colonies (50 cfu).It was a patient sample.".

• 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: 17358172
• MDR Text Key: 319943240
• Report Number: 1119779-2023-00786
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• 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: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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