MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD MULTI-CHECK¿

Model Number	340911
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.7 initial reporter addr 1: (b)(6).G.7 pma / 510(k)# k961610, k982231.H.3.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 that while using the bd multi-check¿ that there was a label issue.The following information was provided by the initial reporter: there has been a change to the reference range product insert and the ruo range values are no longer provided.The customer has not been informed of this change which impacts their process and sop.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00108 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.See h.10.
Event or Problem Description
It was reported that while using the bd multi-check¿ that there was a label issue.The following information was provided by the initial reporter: there has been a change to the reference range product insert and the ruo range values are no longer provided.The customer has not been informed of this change which impacts their process and sop.

• Brand Name: BD MULTI-CHECK¿
• Common Device Name: NA
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16979436
• Report Number: 2916837-2023-00108
• Device Sequence Number: 6443115
• Product Code: GKZ
• UDI-Device Identifier: 00382903409112
• UDI-Public: 00382903409112
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K961610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Other
• Device Expiration Date: 06/02/2023
• Device Model Number: 340911
• Device Catalogue Number: 340911
• Device Lot Number: BM0523N
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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