MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES 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	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use with bd multitest¿ erroneous results were obtained.There was no patient impact.The following information was provided by the initial reporter: tbnk run with 1/3 of patients showing a small percentage of contamination.Tbnk lot 42267 exp 30.06.2024, this bottle was the 1st bottle of 8 which was opened on 29.09.23 for pre-testing.1.Are there erroneous results on patient samples from diagnostic test? (answer: yes).2.Was there any delay of treatment due to the issue? (answer: no).3.If patient samples were redrawn, was there any change or delay of treatment? (answer: n/a, patient samples not redrawn.) 4.Was there any physical harm/injury to the patient due to the issue? (answer: no).
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences g.1 - reporting office contact - (b)(4) g.1 - manufacturing site contact - (b)(4).H6.Investigation summary: bd acknowledges the customer's experience regarding the indicated failure mode, customer observed a cd3+cd8+cd4- small population dimmer than the cd8+ cluster in the cd3/cd8 dot plot with 6-color bnk reagent part 644611-42267.The cause of the reported issue of a cd3+cd8+ scattered events observed to be dimmer than the cd3+cd8+ cluster population was not determined.The issue can be due to the stickiness of the apc-cy7 tandem fluorophore used to conjugate to cd8 antibody.The material passed all the product specification when release.Performance check of the complaint lot was compared to a reference lot and both lots performed comparably.Bd is continually monitoring complaints received for this device and reported issues to identify emerging trends.
Event or Problem Description
It was reported that during use with bd multitest¿ erroneous results were obtained.There was no patient impact.The following information was provided by the initial reporter: tbnk run with 1/3 of patients showing a small percentage of contamination.Tbnk lot 42267 exp 30.06.2024, this bottle was the 1st bottle of 8 which was opened on 29.09.2023 for pre-testing.1.Are there erroneous results on patient samples from diagnostic test? (answer: yes) 2.Was there any delay of treatment due to the issue? (answer: no) 3.If patient samples were redrawn, was there any change or delay of treatment? (answer: n/a, patient samples not redrawn) 4.Was there any physical harm/injury to the patient due to the issue? (answer: no).

• Brand Name: BD MULTITEST¿
• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18017513
• Report Number: 2916837-2023-00209
• Device Sequence Number: 18043435
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 06/30/2024
• Device Catalogue Number: 644611
• Device Lot Number: 42267
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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