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 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k130470.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 running samples with bd max" system, bd max" instrument false negative results were obtained.Testing was repeated and validated and the results were positive.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: bubbles in the cartridge affect the final measurement of the reaction, giving invalid or negative results for samples that when repeated are valid (pr positive) or positive.

Manufacturer Narrative

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 false negative results due to bubbles in the cartridges.Customer also reported that they had issue with their mouse.Field service was dispatched.Field service performed an alignment check to correct the bubble issue and replaced the aio to address the mouse issue.Instrument was returned to customer functional.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) 2020, 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 failure mode reported.No samples were returned for investigation, therefore return sample analysis is not performed.Root cause cannot be determined with the information provided.Complaint is confirmed by field service during dispatch.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.

Event Description

It was reported that while running samples with bd max¿ system, bd max¿ instrument false negative results were obtained.Testing was repeated and validated and the results were positive.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: bubbles in the cartridge affect the final measurement of the reaction, giving invalid or negative results for samples that when repeated are valid (pr positive) or 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12507397
• MDR Text Key: 272518018
• Report Number: 1119779-2021-01553
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 00382904419165
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 02/16/2022

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: 08/23/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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