MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD® HLA-B27 KIT

Catalog Number	340183
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	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 were erroneous results during use with the bd® hla-b27 kit.The following information was provided by the initial reporter: the customer found that lot number 2349915 had almost all positive results falling into the gray zone, requiring confirmation through pcr and all are confirmed hla-b27 positive, this happened for 2-3 days.After switching to lot 3096158 and conducting a comparison, the new batch showed positive results.However, the fluorescence intensity of the old batch(2349915) still remained in the gray zone.Please refer to the attached results.
Event or Problem Description
It was reported that there were erroneous results during use with the bd® hla-b27 kit.The following information was provided by the initial reporter: the customer found that lot number 2349915 had almost all positive results falling into the gray zone, requiring confirmation through pcr and all are confirmed hla-b27 positive, this happened for 2-3 days.After switching to lot 3096158 and conducting a comparison, the new batch showed positive results.However, the fluorescence intensity of the old batch(2349915) still remained in the gray zone.Please refer to the attached results.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 reporting office - (b)(6) g.1 reporting office contact - (b)(6) g.1 manufacturing site contact - (b)(6) after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.The customer reported that there was a difference in fluorescence intensity between 2 lots, but both results were positive.There was no erroneous result or patient harm reported.Therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD® HLA-B27 KIT
• Common Device Name: NA
• 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: 17386190
• Report Number: 2916837-2023-00148
• Device Sequence Number: 5928948
• Product Code: MZI
• UDI-Device Identifier: 00382903401833
• UDI-Public: 00382903401833
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: BK050073
• 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): 02/08/2024

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: 07/31/2023
• Device Catalogue Number: 340183
• Device Lot Number: 2349915
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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