MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA

Model Number	240826
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	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while testing with bd bbl¿ coagulase plasma, rabbit with edta a performance issue resulting in auto-agglutination occurred.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: d-at what temperature was the product shipped to you?  room temperature.How did you store reconstituted plasma?  using deionized water.Is this issue occurring with plasma from both lots?  yes.  c¿customer problem: coag plasma 240826 auto-agglutination.Photos or returns requested? 1 photo is attached, requested photos of affected product with lot number.It was reported that coag plasma 240826 auto-agglutination.
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.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1182949.Medical device expiration date: 06/23/2024.Device manufacture date: 07/01/2021.
Additional Manufacturer Narrative
Investigation summary: returned kits of both lots were received for this complaint; two kits of lot 1084793 and 1 kit of lot 1182949 were received in the return.Based on the complaint notes and photo provided, the customer is observing autoagglutination after preparation of the test tubes or during testing.No bacterial culture was mentioned, therefore the complaint lots were tested with nothing added to each tube other than the coagulase plasma.For this testing, two retained samples from each lot were tested along with two samples from each of the returned kits for a total of (b)(4) samples tested (6 of lot 1084793 and 4 of lot 1182949); all samples were rehydrated with autoclaved deionized water.To test each sample, test tubes containing 0.5 ml of the coagulase plasma only were prepared.All tubes were incubated at 37°c and read every two hours, up to 6 hours.Incubation continued to 24 hours when the final reading was completed.Results were as follows: (b)(4) samples (2 retain and 4 return) of lot 1084793 - no clotting or agglutination was observed at any of the readings (b)(4) samples (2 retain and 2 return) of lot 1182949 - no clotting or agglutination was observed at any of the readings the complaint was not confirmed based on this testing.The batch history records for the lots were reviewed and found satisfactory.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 positive results.No corrective action is needed at this time.
Event or Problem Description
It was reported while testing with bd bbl¿ coagulase plasma, rabbit with edta a performance issue resulting in auto-agglutination occurred.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: d.At what temperature was the product shipped to you? ¿ room temperature how did you store reconstituted plasma? ¿ using deionized water is this issue occurring with plasma from both lots? - yes   c.Customer problem: coag plasma 240826 auto-agglutination photos or returns requested? 1 photo is attached, requested photos of affected product with lot number it was reported that coag plasma 240826 auto-agglutination.

• Brand Name: BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA
• Common Device Name: COAGULASE PLASMA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12913619
• Report Number: 1025402-2021-00007
• Device Sequence Number: 4820008
• Product Code: JTL
• UDI-Device Identifier: 30382902408261
• UDI-Public: 30382902408261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/02/2021

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: 03/10/2024
• Device Model Number: 240826
• Device Catalogue Number: 240826
• Device Lot Number: 1084793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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