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 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Pma 510k: k111860, k130470.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd max¿ system, bd max¿ instrument two samples are not being detected for yersinia the same samples have been tested on cin agar as positive for yersinia, no erroneous results have been sent.The two samples have been retested on bd max and gave pos results for yersinia but with high ct.It seems that these samples was closed to the detection limit of our test.Results were false negative.The following information was provided by the initial reporter: us results as it was not clear to the investigators based on the task answered below.Thank you! two patient samples have not been detected for yersinia with the bd max.As the same samples have been tested on cin agar as positive for yersinia, no erroneous results have been sent.The two samples have been retested on bd max and gave pos results for yersinia but with high ct.It seems that these samples was closed to the detection limit of our test.Results were false negative.

Manufacturer Narrative

H6.Investigation summary: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6) had a "false negative." customer reported that they are concerned about false negative results for yersinia while running the bd max extended enteric bacterial panel assay.Customer is requesting testing application support.Bd application support specialists contacted the customer to discuss the results and obtain files for review by bd.Bd service & quality reviewed the customer run files associated with the suspected false negative results.Their analysis indicated no instrument issues and a possible specimen issue.Bd service followed-up with the customer the following week and no further issues have been reported by the customer.Returned sample analysis consisted of review of customer run files, which indicated no evidence of an instrument issue.Review of device history record for instrument (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument (b)(6) , and three additional work orders were observed on (b)(6) 2022, (b)(6) 2022, and (b)(6) 2022 for the complaint failure mode reported.

Event Description

It was reported that bd max¿ system, bd max¿ instrument two samples are not being detected for yersinia the same samples have been tested on cin agar as positive for yersinia, no erroneous results have been sent.The two samples have been retested on bd max and gave pos results for yersinia but with high ct.It seems that these samples was closed to the detection limit of our test.Results were false negative.The following information was provided by the initial reporter: us results as it was not clear to the investigators based on the task answered below.Two patient samples have not been detected for yersinia with the bd max.As the same samples have been tested on cin agar as positive for yersinia, no erroneous results have been sent.The two samples have been retested on bd max and gave pos results for yersinia but with high ct.It seems that these samples was closed to the detection limit of our test.Results were false negative.

• 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: 16043364
• MDR Text Key: 306838042
• Report Number: 1119779-2022-01537
• Device Sequence Number: 1
• Product Code: OOI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SEE H.10
• 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: 03/31/2023

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: 12/07/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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