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 01/19/2022

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 result.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, translated from french: "customer reports they had problems with false negatives on certest sars-cov-2 (444215) test.This related to the reading of the amplification curves, reader b.".

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.

Event Description

It was reported that while testing for sars-cov-2, the bd max¿ system, bd max¿ instrument produced a false negative result.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, translated from french: "customer reports they had problems with false negatives on certest sars-cov-2 (444215) test.This related to the reading of the amplification curves, reader b.".

Manufacturer Narrative

H.6.Investigation: 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 side b.Field service was replaced.Field service replaced the b side reader and normalized it.Field service performed a successful qualification run on side b.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)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 analysis was not performed.Root cause cannot be determined with the information provided.Complaint is confirmed by field service during dispatch.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.

• 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: 13641885
• MDR Text Key: 290537889
• Report Number: 1119779-2022-00330
• 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: K130470
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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