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

Catalog Number 227901

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

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 Description

It was reported while using the bd difco¿ haemophilus influenzae antiserum type d the user received weak agglutination (false positive results) for a patient sample.No health impact or consequence reported.Report 3 of 3.

• Brand Name: BD DIFCO¿ HAEMOPHILUS INFLUENZAE ANTISERUM TYPE D
• Type of Device: 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: 18982688
• MDR Text Key: 338701263
• Report Number: 1025402-2024-00007
• Device Sequence Number: 1
• Product Code: GRP
• UDI-Device Identifier: 00382902279013
• UDI-Public: (01)00382902279013
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 227901
• Device Lot Number: 3173176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1