MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO SHIGELLA ANTISERUM POLY GROUP A; ANTISERA, ALL TYPES, SHIGELLA SPP.

Model Number	228341
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	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd difco¿ shigella antiserum poly group a atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that there is no agglutination for s.Dysenteriae serogroup 3 when using cat 228341 lot 9354479.Customer problem: customer reports no agglutination for s.Dysenteriae serogroup 3 when using cat 228341 lot 9354479.".

• Brand Name: BD DIFCO SHIGELLA ANTISERUM POLY GROUP A
• Common Device Name: ANTISERA, ALL TYPES, SHIGELLA SPP.
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• MDR Report Key: 11879165
• Report Number: 1025402-2021-00004
• Device Sequence Number: 4339278
• Product Code: GNB
• UDI-Device Identifier: 00382902283416
• UDI-Public: 00382902283416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 12/09/2022
• Device Model Number: 228341
• Device Catalogue Number: 228341
• Device Lot Number: 9354479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1