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 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.

Event Description

It was reported that while using the bd max¿ system, bd max¿ instrument false negative results were obtained by the laboratory personnel.A repeat test was performed on another bd max and the result was positive.The customer stated that results were not reported out so there was no report of patient impact.Assays used: unspecified sarscov-2 n1n2 the following information was provided by the initial reporter: "max result positive.".

Manufacturer Narrative

H6: investigation summary the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6) had a "correlation/repro/discrepant".Customer reported that they had two patient results that were negative on this instrument, but on another bd max instrument, the result was positive for n1/n2.Customer performed a new validation and no issue was noted.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 were returned for investigation, therefore returned sample analysis was not performed.Root cause cannot be determined with the information provided.Complaint is unconfirmed as no information was provided to determine an instrument issue.See h10.

Event Description

It was reported that while using the bd max¿ system, bd max¿ instrument false negative results were obtained by the laboratory personnel.A repeat test was performed on another bd max and the result was positive.The customer stated that results were not reported out so there was no report of patient impact.Assays used: unspecified sarscov-2 n1n2 the following information was provided by the initial reporter: "max result positive;".

• 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: 13090939
• MDR Text Key: 285561472
• Report Number: 1119779-2021-02050
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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