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 01/28/2022

Event Type  malfunction  

Event Description

It was reported that while testing for sars-cov-2, the bd max¿ system, bd max¿ instrument produced a false negative when the n2 showed up positive in the patient results.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.Assays used: sars-cov-2 the following information was provided by the initial reporter: "customer asked why his cov-2 result is neg with n2 being pos in patient result".

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 25-may-2022.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 false negative results on a covid run.Customer reported that they had n2 positive result, but the result called for cov-2 negative.Customer changed the result logic, deleted reinstalled the udp provided by service.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 01apr2020, 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.Returned sample analysis consisted of review of snippet that shows the result logic.In the result logic, it shows that the result logic was set where n2 positive and rnasep negative will result in a negative covid result.Root cause is determined to be due to an incorrect udp setting.Complaint is unconfirmed by service.Review of risk management files confirms there are no new, modified, or additional risks associated with this failure mode.

Event Description

It was reported that while testing for sars-cov-2, the bd max¿ system, bd max¿ instrument produced a false negative when the n2 showed up positive in the patient results.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.Assays used: sars-cov-2 the following information was provided by the initial reporter: "customer asked why his cov-2 result is neg with n2 being pos in patient result".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13581341
• MDR Text Key: 286008058
• Report Number: 1119779-2022-00284
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130470
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• 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