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 02/07/2024

Event Type  malfunction  

Event Description

It was reported that during use with the bd max¿ system, bd max¿ instrument, all samples were positive.There was no report of patient impact.

Manufacturer Narrative

G5.Multiple 510(k): k111860, k130470 h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had an "false positive" error.Customer reported that they are receiving all false positive results on a run for max nov/rov and the issue has risen and they suspected carryover.Application specialist visit onsite and found no issue with the instrument.Review of device history record for instrument serial number, ct0540 is not required because this complaint does not allege an early life failure or a failure at install.Device was installed on (b)(6) 2020 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 investigation was not performed.Root cause cannot be determined with the information provided.Complaint is unconfirmed as all testing shows no issue with the instrument.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 during use with the bd max¿ system, bd max¿ instrument, all samples were positive.There was no report of patient impact.Assays used: norovirus/rotavirus.

Manufacturer Narrative

The following fields were updated with additional information: b5.It was reported that during use with the bd max¿ system, bd max¿ instrument, all samples were positive.There was no report of patient impact.Assays used: norovirus/rotavirus.B6.Relevant tests/laboratory data: repeat testing on second max instrument and at external lab.Positive results not confirmed.

Event Description

It was reported that during use with the bd max¿ system, bd max¿ instrument, all samples were positive.There was no report of patient impact.Assays used: norovirus/rotavirus.

• 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: 18832680
• MDR Text Key: 337438900
• Report Number: 1119779-2024-00175
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: (01)00382904419165
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• 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