MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-JK(A); SERACLONE ANTI-JK(A)

Catalog Number	808179100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false negative reaction of seraclone anti-jka.The customer stated that she tested seraclone anti-jka with three different heterozygous red blood cells: one reacted weak positive, one was negative to weak and the third red blood cell showed a false negative reaction.The customer did not provide a date of event.The customer returned a sample of the allegedly defective product but not the red blood cell that had caused the false negative test result.Our quality control laboratory tested the complaint material as well as their retention sample of the supposedly defective lot for potency and specificity.The testing was performed in parallel with a reference lot.All reagent samples showed comparable results and exceeded the minimum titer.Within the testing for specificity the complaint sample, the retention sample and reference were tested with different samples for specificity.Again, all three reagents showed comparable results.All positive and negative reactions were correct.The positive reactions were strongly positive (4+).We did not observe any false negative or weakened reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We reached out to the customer to verify that she sent the correct product sample because we could not reproduce the false negative reaction in our qc lab.We are still waiting for her confirmation.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative reaction of seraclone anti-jka.The customer stated that she tested seraclone anti-jka with three different heterozygous red blood cells: one reacted weak positive, one was negative to weak and the third red blood cell showed a false negative reaction.The customer returned a sample of the allegedly defective product but not the red blood cell that had caused the false negative test result.Our quality control laboratory tested the complaint material as well as their retention sample of the supposedly defective lot for potency and specificity.The testing was performed in parallel with a reference lot.All reagent samples showed comparable results and exceeded the minimum titer.Within the testing for specificity the product sample returned by the customer, the retention sample, and a reference were tested with different samples for specificity.Again, all three reagents showed comparable results.All positive and negative reactions were correct.The positive reactions were strongly positive (4+).We did not observe any false negative or weakened reaction.The testing was done according to the instruction for use (ifu): tube test with an incubation for 15 minutes at room temperature followed by centrifugation for 60 s at 800 to 1000 x g.Additionally, the product sample returned by the customer as well as the retention sample were tested with reagent red blood cells from immucor.Again, all positive and negative reactions were correct.The positive reactions were strongly positive.The reagent red blood cells were used ready for use and tested according to the ifu.Based on the investigation the complaint was classified as unjustified.The complaint sample as well as the retention sample reacted as expected.All acceptance criteria regarding specificity and potency were met.We have no explanation for the false negative reaction of the reagent at the customer's site as the vial in question met all acceptance criteria.However, we would like to point out that the cell buttons must dislodged gently after centrifugation.Otherwise, the agglutinates of weak positive reactions might be destroyed.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-JK(A)
• Common Device Name: SERACLONE ANTI-JK(A)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 18778201
• Report Number: 9610824-2024-00002
• Device Sequence Number: 11834615
• Product Code: QHR
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)240907(10)9302080-01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 125231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: Health Professional
• Device Expiration Date: 09/07/2024
• Device Catalogue Number: 808179100
• Device Lot Number: 9302080-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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