MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTI-CHECK CD4 LOW CONTROL; COUNTER, DIFFERENTIAL CELL

Catalog Number	340914
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.G.5.Pma / 510(k)#: k150815.G.5.Pma / 510(k)#: k982231.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that there was a labeling issue with bd multi-check cd4 low control.The following information was provided by the initial reporter: multi-check cd4 low control product (#340914 bm0823l) box contains another product, multi-check control (#340911; bm0823n) tube, so complaints are coming in.It's been alleged by one of our distributors and the confirmed qty was 5 boxes.And it needs to confirm whether it's just a correct product (multi-check cd4 low control (#340914; bm0823l)) with mislabeled or other products(multi-check control (#340911; bm0823n) packaged.Also please note that the product¿s expiration period is just a month, so many customers are worried about their testing schedule, especially in the hospitals.
Event or Problem Description
It was reported that there was a labeling issue with bd multi-check cd4 low control.The following information was provided by the initial reporter: multi-check cd4 low control product (#340914 bm0823l) box contains another product, multi-check control (#340911; bm0823n) tube, so complaints are coming in.It's been alleged by one of our distributors and the confirmed q¿ty was 5 boxes.And it needs to confirm whether it's just a correct product (multi-check cd4 low control (#340914; bm0823l)) with mislabeled or other products(multi-check control (#340911; bm0823n) packaged.Also please note that the product¿s expiration period is just a month, so many customers are worried about their testing schedule, especially in the hospitals.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00170 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.H3 other text : see h.10.

• Brand Name: BD MULTI-CHECK CD4 LOW CONTROL
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17560797
• Report Number: 2916837-2023-00170
• Device Sequence Number: 19696547
• Product Code: GKZ
• UDI-Device Identifier: 00382903409143
• UDI-Public: 00382903409143
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 09/02/2023
• Device Catalogue Number: 340914
• Device Lot Number: BM0823L
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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