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	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that erroneous results were observed during use with bd multitest¿.The following information was provided by the initial reporter: erroneous results: yes.Detailed erroneous results: results are not reported, customer has compared batches and notified me of the performance issue.Customer is seeing some non specific staining.They have provided data on a different lot that looks fine.
Additional Manufacturer Narrative
E.1.Initial reporter address 1: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131 g.1 - reporting office contact - fahmy razak.G.1 - manufacturing site contact - fahmy razak.H.6 investigation summary: based on the investigation results, the reported issue of non-specific staining aggregates was confirmed.Investigation results that were performed on the indicated failure mode were the following: evaluation of details/data provided by the customer.Batch history review (bhr): the product met specifications prior to release by flow cytometry test vs reference lot prior to release.The potential cause cannot be determined.However, non-specific binding may occur in flow cytometry due to poor washing of stained samples, aging of samples during storage or reagent deterioration if not properly stored/handled as recommended the issue was resolved by the customer being supplied with a new lot.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 erroneous results were observed during use with bd multitest¿.The following information was provided by the initial reporter: erroneous results: yes.Detailed erroneous results: results are not reported, customer has compared batches and notified me of the performance issue.Customer is seeing some non specific staining.They have provided data on a different lot that looks fine.

• 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: 17683500
• Report Number: 3008352382-2023-00127
• Device Sequence Number: 2599011
• Product Code: GKZ
• UDI-Device Identifier: 00382906446114
• UDI-Public: 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 05/31/2024
• Device Catalogue Number: 644611
• Device Lot Number: 72236
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 03/28/2024
• 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