MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D; ANTISERA, ALL TYPES, H. INFLUENZA

Catalog Number	227901
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 the bd difco¿ haemophilus influenzae antiserum type d, a false positive result was obtained.There was no report of patient impact.Report 3 of 3.
Additional Manufacturer Narrative
H6.Investigation summary: no returns were received for this complaint.To investigate the complaint on catalog 227901, lot 3159723, a retained sample of the complaint lot was tested, according to the product instructions for use, with available cultures representing haemophilus influenzae type d.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 of saline to check for roughness.Each slide was rotated for 1 minute before reading the reaction.Results were as follows: 4+ reactions were observed with the retain tested, with the type d cultures tested.No reactivity was observed when the cultures were tested in saline.The complaint was not confirmed based on the testing performed.The batch history record for the lot was reviewed and found satisfactory.Complaints for the product line were reviewed.There have been no other complaints in the three-year period reviewed; bd will continue to monitor for trends.No corrective action is needed at this time.
Event or Problem Description
It was reported that during use with the bd difco¿ haemophilus influenzae antiserum type d, a false positive result was obtained.There was no report of patient impact.Report 3 of 3.

• Brand Name: BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D
• Common Device Name: ANTISERA, ALL TYPES, H. INFLUENZA
• 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: 18894873
• Report Number: 1025402-2024-00004
• Device Sequence Number: 6248236
• Product Code: GRP
• UDI-Device Identifier: 00382902279013
• UDI-Public: (01)00382902279013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 02/16/2026
• Device Catalogue Number: 227901
• Device Lot Number: 3159723
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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