MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-PANEL 11; IH-PANEL 11; 11X4 ML

Catalog Number	814070100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
A patient was identified as carrying an alloantibody, anti[-k, using the gel method.To further investigate, the laboratory performed an additional antibody identification using tube testing with papain, which revealed a second alloantibody, anti-e.This anti-e was not detectable using the ih-panel 11.
Event or Problem Description
A patient was identified as carrying an alloantibody, anti-k, using the gel method.To further investigate, the laboratory performed an additional antibody identification using tube testing with papain, which revealed a second alloantibody, anti-e.This anti-e was not detectable using the ih-panel 11.Based on the data and information provided, we shared the feedback from our scientific affairs officer: - regarding the anti-e antibody, it is a classic case of a naturally occurring anti-e detectable only by enzyme.This specificity is more common than what we think.- regarding the anti-k antibody, it is possible that it comes from the previous transfusion as primary immunization.The timing of antibody production does not necessarily lead to a severe transfusion reaction and the antibody production may remain unnoticed, reason why a antibody screening should be tested a month after transfusion.The retention tests performed by dreieich confirmed the customer findings and that the patient sample contains a natural anti-e antibody detectably only in enzyme technique.There is no manufacturing issue with the reagent as they have the expected result with the qc tests.Therefore, the situation is patient sample related.Resolution: the retention tests with the patient samples shipped allowed us to confirm the customer findings that the patient sample contains a natural anti-e antibody detectably only in enzyme technique.There is no manufacturing issue with the reagent as they have the expected result with the qc tests.Therefore, the situation is patient sample related.We also shared the information that the antibody detected in enzyme technique only like the anti-e antibody are generally not considered as clinically significant and rarely cause hemolytic transfusion reactions.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS IH-PANEL 11
• Common Device Name: IH-PANEL 11; 11X4 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: monica albarca ; industriestrasse 1; dreieich, ; GM
• MDR Report Key: 24312973
• Report Number: 9610824-2026-00003
• Device Sequence Number: 4837624
• Product Code: KSZ
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)260209(10)9550011
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: 125208
• 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): 02/11/2026

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: 02/09/2026
• Device Catalogue Number: 814070100
• Device Lot Number: 9550011
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IH-1000, SN (B)(6); IH-1000, SN (B)(6); IH-CELL I-II-III, LOT 9550011, EXPIRY 02/09/2026; IH-CELL I-II-III, LOT 9550011, EXPIRY 02/09/2026; IH-PANEL 11 PAPAIN, LOT 9550011, EXPIRY 02/09/2026; IH-PANEL 11 PAPAIN, LOT 9550011, EXPIRY 02/09/2026
• Patient Sex: Unknown