MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA O ANTISERUM GROUP E FACTORS 1, 3, 10, 15, 19, 34; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	228191
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	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd difco¿ salmonella o antiserum group e factors 1, 3, 10, 15, 19, 34 a weak agglutination reaction occurred.No health impact or consequence reported.
Additional Manufacturer Narrative
E1: (b)(6) hospital.Investigation summary: no return sample was received for this complaint.The customer returned one photo; a photo analysis was performed.The customer performed a comparison between two lots of salmonella o antiserum group e, lot 3089158 and 3166223.Lot 3089158 on the left-hand side shows a 3+ agglutination, which is typical and compliant with the instructions for use.Lot 3166223 on the right-hand side shows a 4+ agglutination, which is also a typical result.Based on the photo analysis performed the complaint is not confirmed.To further investigate the complaint on catalog 228191, lot 3089158, a retained sample of the complaint lot was tested, according to the products instructions for use, with cultures representing salmonella o group e.For each antiserum test, a portion of culture was removed from the agar plate and mixed into one drop of antiserum on a slide.In addition, each culture was tested in a drop saline to check for roughness.Each slide was rotated for 1 minute before reading the reaction.Results are as follows: 4+ reactions were observed with the retained vial, with all cultures tested.No reactivity was observed when the culture was tested in saline.The complaint was not confirmed based on the testing performed.The complaint investigation included a review of the batch history record for the product lot.The batch history record for the lot was reviewed and found satisfactory.Complaints for the product line were reviewed.There have been seven complaints received on the product lot number in the three-year period reviewed; bd will continue to monitor for trends.No corrective action is required at this time.

• Brand Name: BD DIFCO¿ SALMONELLA O ANTISERUM GROUP E FACTORS 1, 3, 10, 15, 19, 34
• Common Device Name: ANTISERA, ALL GROUPS, SALMONELLA SPP.
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19587014
• Report Number: 1025402-2024-00008
• Device Sequence Number: 7392305
• Product Code: GRM
• UDI-Device Identifier: 00382902281917
• UDI-Public: (01)00382902281917
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 04/13/2026
• Device Catalogue Number: 228191
• Device Lot Number: 3089158
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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