MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Catalog Number 441916

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: na.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g.5.Pma / 510(k)#: 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 during use with bd max¿ system, bd max¿ instrument false negative results were obtained.Confirmatory culture and cepheid cpo assay were positive.Results were not reported and there was no report of patient impact.The following information was provided by the initial reporter: the customer is complaining about discordant results between bd max cpo assay and cepheid cpo assay.They report bd max cpo negatives, confirmed with culture, that show positive with cepheid cpo assay.Confirmed with culture, that gave a positive signal for the bd max cpo assay (high ct).

Event Description

It was reported that during use with bd max¿ system, bd max¿ instrument false negative results were obtained.Confirmatory culture and cepheid cpo assay were positive.Results were not reported and there was no report of patient impact.The following information was provided by the initial reporter: the customer is complaining about discordant results between bd max cpo assay and cepheid cpo assay.They report bd max cpo negatives, confirmed with culture, that show positive with cepheid cpo assay.Confirmed with culture, that gave a positive signal for the bd max cpo assay (high ct).

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" result.Customer reported that they have received a negative results on cpo assay with culture confirming positive.Service reviewed the ct data and determined that a side is contaminated that it is saturating the reader.Customer performed a thorough decontamination of the instrument.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 20jan2021, 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 is determined to be due to contamination of the instrument.Complaint is unconfirmed by application specialist.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.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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17515354
• MDR Text Key: 321164347
• Report Number: 1119779-2023-00879
• 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: 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: 09/08/2023

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 Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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