MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MULTITEST¿; COUNTER, DIFFERENTIAL CELL

Catalog Number	644611
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	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd multitest¿ erroneous results were observed.No patient impact was reported.The following information was provided by the initial reporter: non specific population debri observed in all patient samples stained with the bd 6-colour tbnk reagent.Repeated with new vial of same reagent, issue persists.Changed trucount tubes and facslyse solution, issue persists.
Additional Manufacturer Narrative
B3: date of event is unknown.B3.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
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 while using bd multitest¿ erroneous results were observed.No patient impact was reported.The following information was provided by the initial reporter: non specific population/debri observed in all patient samples stained with the bd 6-colour tbnk reagent.Repeated with new vial of same reagent, issue persists.Changed trucount tubes and facslyse solution, issue persists.

• Brand Name: BD MULTITEST¿
• 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: 18763244
• Report Number: 2647876-2024-00040
• Device Sequence Number: 4500063
• Product Code: GKZ
• UDI-Device Identifier: 00382906446114
• UDI-Public: (01)00382906446114
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090967
• 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
• Report Date (Section B): 06/28/2024

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: 09/30/2024
• Device Catalogue Number: 644611
• Device Lot Number: 49510
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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