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

Model Number	441927
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Pma / 510(k)#: there were multiple 510k numbers reported to be involved: k111860, k130470.
Event or Problem Description
It was reported that while using bd mbd max¿ instrument, remanufactured it acquired false negatives on patient samples.There was no patient impact.The following information was provided by the initial reporter: "customer reports false negatives on patient samples".
Event or Problem Description
This mdr supersedes all previous mdr.The previous mdr dt was completed in error with the incorrect reportability.It was reported that while using bd mbd max¿ instrument, remanufactured it acquired false negatives on patient samples.There was no patient impact.The following information was provided by the initial reporter: "customer reports false negatives on patient samples.".
Additional Manufacturer Narrative
This mdr supersedes all previous mdr.The previous mdr dt was completed in error with the incorrect reportability.This complaint is not reportable.Reference new dt (b)(4).
Event or Problem Description
This mdr supersedes all previous mdr.The previous mdr dt was completed in error with the incorrect reportability.It was reported that while using bd mbd max¿ instrument, remanufactured it acquired false negatives on patient samples.There was no patient impact.The following information was provided by the initial reporter: "customer reports false negatives on patient samples".
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

• Brand Name: BD MAX¿ INSTRUMENT, REMANUFACTURED
• 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: 15225544
• Report Number: 1119779-2022-01108
• Device Sequence Number: 5851689
• Product Code: OOI
• UDI-Device Identifier: 00382904419271
• UDI-Public: 00382904419271
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: 441927
• Device Catalogue Number: 441927
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 12/12/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/14/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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