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 11/21/2022

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.Pma/510k info: k111860, k130470.

Event Description

It was reported that bd max¿ system, bd max¿ instrument false negatives occurred.The following information was provided by the initial reporter: for a problem with a sample on the bd max that was given as negative and they did the immunochromatographic analysis and it gave a slight positive clostridium kit.Hazard, injury or erroneous results? no.

Event Description

It was reported that bd max¿ system, bd max¿ instrument false negatives occurred.The following information was provided by the initial reporter: for a problem with a sample on the bd max that was given as negative and they did the immunochromatographic analysis and it gave a slight positive clostridium kit.Hazard, injury or erroneous results? no.

Manufacturer Narrative

H.6 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 received a suspected false negative result for a patient specimen while running the c.Diff assay.Customer states they performed a confirmatory immunochromatographic analysis of the sample which indicated a positive result.The customer database was provided to bd service specialists for further analysis which revealed that the instrument is functioning to specifications and possible evidence of issues with the specific sample tested.This complaint is not confirmed as no problem was found with the instrument and it alludes to an issue with the specimen.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 instrument ct1989 is not required because this complaint does not allege a functional issue with the instrument and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument ct1989, and no additional work orders 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.

• 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: 15902627
• MDR Text Key: 307315421
• Report Number: 1119779-2022-01442
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/20/2023

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: 11/21/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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