MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD STEM CELL CONTROL KIT 15 TESTS IVD; COUNTER, DIFFERENTIAL CELL

Catalog Number	662967
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after using bd stem cell control kit 15 tests ivd they acquired erroneous results.The following information was rpovided by the initial reporter: the customer found that as long as this batch of lot is stained, in the apc vs ssc and cd4 vs cd8 graphs, there is noise, but other lots are normal without noise.
Additional Manufacturer Narrative
E.4- initial reporter phone number: (b)(6).E.12- initial reporter facility name: (b)(6) hospital.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 after using bd stem cell control kit 15 tests ivd they acquired erroneous results.The following information was provided by the initial reporter: the customer found that as long as this batch of lot is stained, in the apc vs ssc and cd4 vs cd8 graphs, there is noise, but other lots are normal without noise.
Additional Manufacturer Narrative
The following fields have been updated: g.1.Reporting office: becton dickinson and company bd biosciences.G.2.Reporting office contact: fahmy razak - mdr.G.4.Manufacturing site contact: fahmy razak - mdr.H.6.Investigation summary: based on the investigation results, the reported issue of unusual staining pattern nonspecific staining while using product 662967 (bd multitest 6-color tbnk reagent, ivd) lot 17582 was confirmed but not attributed to reagent product performance or quality, considered an isolated event with no impact to patient health or safety.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
H6.Investigation summary: based on the investigation results, the reported issue (non-specific staining creating unusual staining patterns for cd4+cd+8 populations) was confirmed.Investigation results that were performed on the indicated failure mode were the following: data provided by customer was reviewed.Retain testing results showed the presence of a non-specific staining.Potential cause is determined to be manufacturing related.Additional controls have been put in place in the manufacturing stage specific to the supplied component.Corrective action was initiated to address the root cause and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that after using bd stem cell control kit 15 tests ivd they acquired erroneous results.The following information was rpovided by the initial reporter: the customer found that as long as this batch of lot is stained, in the apc vs ssc and cd4 vs cd8 graphs, there is noise, but other lots are normal without noise.

• Brand Name: BD STEM CELL CONTROL KIT 15 TESTS IVD
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18320074
• Report Number: 2647876-2023-00653
• Device Sequence Number: 12500549
• Product Code: GKZ
• UDI-Device Identifier: 00382906629678
• UDI-Public: (01)00382906629678
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K170974
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 07/31/2024
• Device Catalogue Number: 662967
• Device Lot Number: 17582
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 07/03/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/06/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94830
• Patient Sequence Number: 1
• Patient Sex: Unknown