MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BBL COAGULASE PLASMA, RABBIT WITH EDTA; PLASMA, COAGULASE, HUMAN, HORSE AND RABBIT

Model Number	240827
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	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: returns were expected but none were received for this complaint.Additional information was requested regarding the test procedure and equipment being used by the customer, but none was provided.To investigate the complaint on catalog number 240827 batch 0275787, a retained sample of the complaint lot was tested, according to the product instructions for use, with available culture strains of staphylococcus aureus.Based on the complaint notes, the customer is using plate-grown cultures for testing.Therefore, testing of the lot was performed using colonies of each strain of staphylococcus aureus picked directly from agar plates.To test the lot, test tubes containing 0.5 ml of the coagulase plasma were prepared, and 3 or more colonies, up to a 1 ¿l loop full, were picked and added to each tube.All tubes were incubated at 37°c and read every two hours, up to 6 hours.Results were as follows: 2+ to 4+ clots were observed at 2 hours and 4+ clots were observed at 4 and 6 hours with all strains tested; the test was discontinued after 6 hours incubation.The complaint was not confirmed based on this testing.The batch history record for the lot was reviewed and found satisfactory.No quality notifications were issued for the product batch.Complaints for the product were reviewed.There have been no other complaints for this product in the three-year period reviewed; bd quality will continue to monitor closely for trends associated with false negative results.No corrective action is needed at this time.
Event or Problem Description
It was reported that while using 49 bd bbl¿ coagulase plasma, rabbit with edta 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 patient staph aureus isolates are not clotting with use of 240827 lot 0275787.".

• Brand Name: BD BBL COAGULASE PLASMA, RABBIT WITH EDTA
• Common Device Name: PLASMA, COAGULASE, HUMAN, HORSE AND RABBIT
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• MDR Report Key: 12248718
• Report Number: 1025402-2021-00006
• Device Sequence Number: 12036300
• Product Code: JTL
• UDI-Device Identifier: 30382902408278
• UDI-Public: 30382902408278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 09/24/2023
• Device Model Number: 240827
• Device Catalogue Number: 240827
• Device Lot Number: 0275787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1