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 05/24/2023

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ system, bd max¿ instrument there was an unspecified number of false negatives.No erroneous results were reported to health professionals and there was no patient impact.The customer saw that the whole batch was negative and repeated the same batch on another instrument bd max s/n (b)(6).The following information was provided by the initial reporter: "false negative problem on a run.".

Manufacturer Narrative

D.4.Medical device expiration date: unknown e.1.Initial reporter phone #: (b)(6) g.5.Pma / 510(k)#: k111860 , k130470 h.3.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 using bd max¿ system, bd max¿ instrument there was an unspecified number of false negatives.No erroneous results were reported to health professionals and there was no patient impact.The customer saw that the whole batch was negative and repeated the same batch on another instrument bd max s/n (b)(6).The following information was provided by the initial reporter: "false negative problem on a run.".

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd max instrument had a "false negative." customer reported that they had a suspected false negative result on one run.The sample was re-tested on a different bd max instrument and gave a positive result.Bd service specialists consulted with the customer and determined that the customer should perform decontamination of the instrument.The procedure was provided to the customer.The customer confirmed that decontamination was successfully performed, and the instrument was operational again.This complaint is not confirmed as it alludes to a contamination issue.The root cause cannot be determined with the information provided.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Review of device history record for this instrument 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 and no additional cases were observed for the complaint failure mode reported.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h.10.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17134586
• MDR Text Key: 317224670
• Report Number: 1119779-2023-00654
• 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: SEE H.10
• 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: 10/24/2023

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: 05/24/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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