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 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

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 the bd max¿ system, bd max¿ instrument experienced a false negative test result.There was no indication that results were reported, and there was no patient impact.The following information was provided by the initial reporter: the customer ran on sector b without encountering unr on channel 630/665.The problem arose only in the a sector on the bottom side.Action will be taken to check the status of reader a.Rifampicin resistance not present.

Manufacturer Narrative

H6: investigation summary the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had an "correlation/repro/discrepant".Customer reported that they are not seeing rif resistance.Field service was dispatched.Field service replaced #4 pump and nozzles.Field service performed health check for both readers and normalized both readers.Field service performed resistance self-test for both side with no issues.Field service performed a successful qpm test.Instrument was returned to the customer functional.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 (b)(6) 2021, 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 or parts were returned for this complaint and thus, returned sample analysis is not performed.Root cause cannot be determined with the information provided.Complaint is confirmed by field service during dispatched.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.H3 other text : see h10.

Event Description

It was reported that the bd max¿ system, bd max¿ instrument experienced a false negative test result.There was no indication that results were reported, and there was no patient impact.The following information was provided by the initial reporter: the customer ran a run on sector b without encountering unr on channel 630/665.The problem arose only in the a sector on the bottom side.Action will be taken to check the status of reader a.Rifampicin resistance not present.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12633036
• MDR Text Key: 283687082
• Report Number: 1119779-2021-01652
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1