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

Catalog Number	441916
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bd max¿ system, bd max¿ instrument had two occurrences of false positives.It was determined the false results were due to instrument issues.False results were not reported to clinician or patients.The following information was provided by the initial reporter: "false positive results due to bumpy/shaky curves the customer is complaining on false positive results due to bumpy/shaky curves and/or bleeding.They also had some incidences of ind results due to error in result metrics.Therefore our technical service decided to replace the 2 readers in bd max instrument (b)(4).After this action, they are still complaining about false positive results.We discussed this issue internally and after analysing the curves we indeed could see aspecific amplification.Service max cases are in the attached document.Attached you can also find the pdf and csv files of 2 runs no incorrect results were reported to the patient and/or clinician as the customer always look at the curves of positive samples.".
Additional Manufacturer Narrative
Medical device expiration date: na.Pma / 510(k)#: additional 510k number reported: k130470.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported the bd max¿ system, bd max¿ instrument had two occurrences of false positives.It was determined the false results were due to instrument issues.False results were not reported to clinician or patients.The following information was provided by the initial reporter: "false positive results due to bumpy/shaky curves the customer is complaining on false positive results due to bumpy/shaky curves and/or bleeding.They also had some incidences of ind results due to error in result metrics.Therefore our technical service decided to replace the 2 readers in bd max instrument (b)(6).After this action, they are still complaining about false positive results.We discussed this issue internally and after analysing the curves we indeed could see aspecific amplification.Service max cases are in the attached document.Attached you can also find the pdf and csv files of 2 runs no incorrect results were reported to the patient and/or clinician as the customer always look at the curves of positive samples.".
Additional Manufacturer Narrative
H.6.Investigation: the complaint alleges the bd max instrument (catalog number 441916 and serial number (b)(6)) had a "false positive¿.Customer reported that they are receiving false positive on evp.Field service was dispatched and replaced both readers, but the issue still persist.The case has been escalated and is part of an escalation project to determine the issue.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 in (b)(6) 2021, the instrument experienced false positives with adv.Reader a was replaced and both readers were normalized.Returned sample analysis consisted of review of database and run files.Review of the run 2440 shows false positive for adv.Review of the raw vic curve shows that slight but small amplification on shaky curve, but review of the background corrected curve for vic shows that the amplification is not proportional with the raw curve and has a linear overshoot at the end.Review of the fam curve shows that raw fam curve follows closely to the vic background corrected curve with the exception of the overshoot at the end.This is made to believe that there is a level of optical crosstalk.Root cause cannot be determined as the source of the cross talk is still being investigated by the engineering team.Complaint is confirmed by quality review of the run file and database.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.

• Brand Name: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
• Common Device Name: 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: 13743954
• Report Number: 1119779-2022-00426
• Device Sequence Number: 4839240
• Product Code: OOI
• UDI-Device Identifier: 00382904419165
• UDI-Public: 382904419165
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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
• Operator of Device: Other
• Device Catalogue Number: 441916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown