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 had a confirmed anti-c, which we later learned had also been identified at brigham and women's.The antibody was identified without issue, and there was no initial reason to suspect additional antibodies.Given that we are actively investigating several issues with technical support, we elected to run a papain panel.This revealed an anti-e.Upon questioning, the patient's husband (a retired pathologist with excellent recall) stated that she was known to have anti-e dating back to the (b)(6) florida.The patient reports no transfusion history but has had three pregnancies and was previously approached by ortho for plasma donation due to a "rare antibody." we recognize that papain enhances rh antibodies; however, under routine circumstances, we would not have run papain without this additional historical information which is typically unavailable at the time of testing.In this case, transfusing e-positive red cells could have resulted in a delayed hemolytic transfusion reaction.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
A patient had a confirmed anti-c, which we later learned had also been identified at (b)(6).The antibody was identified without issue, and there was no initial reason to suspect additional antibodies.Given that we are actively investigating several issues with technical support, we elected to run a papain panel.This revealed an anti-e.Upon questioning, the patient's husband (a retired pathologist with excellent recall) stated that she was known to have anti-e dating back to the 1970s at (b)(6) hospital in (b)(6).The patient reports no transfusion history but has had three pregnancies and was previously approached by ortho for plasma donation due to a "rare antibody." we recognize that papain enhances rh antibodies; however, under routine circumstances, we would not have run papain without this additional historical information which is typically unavailable at the time of testing.In this case, transfusing e-positive red cells could have resulted in a delayed hemolytic transfusion reaction.Investigation: according to the data provided, the ih-cell iii in antibody screening test and ih-cell 4, 6, 7, 8, 9, 10 and 11 in the antibody identification test are not reacting with the patient sample containing an anti-e antibody according to the antibody identification test in enzyme technique.Without the presence of the anti-c antibody in the patient sample, it would be possible that the antibody screening test does not detect the anti-e antibody and the test would have been negative.However, the customer was able to detect and identify the anti-e antibody in enzyme technique.Based on the data and information provided, we shared the feedback from our scientific affairs officer: - these anti-c and anti-e antibodes could be likely formed during her pregnancy decades ago and have since fallen below the detection limit due to lack of re-exposure.Given her likely ccee (r2r2) phenotype and the very weak anti-e antibody, selecting a r1 (ce) blood unit poses no compatibility risk.- some reference links about antibody evanescence are shared.The retention tests performed by dreieich did not confirm the customer findings, no anti-e antibody has been detected.However, there is no manufacturing issue with the reagents as they have the expected result with the qc tests.In view of this and the weak results obtained by the customer in enzyme technique, we are in the limits of detection for the iat technique as it is mentioned in the "limitations" section from the ifu.Therefore, the situation is mostly patient sample related.Resolution: the retention tests with the patient samples shipped did not allow us to confirm the customer findings that the patient sample contains an anti-e antibody detectably only in enzyme technique.However, there is no manufacturing issue with the reagents as they have the expected result with the qc tests.Therefore, the situation is mostly 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.In this situation, we recommended to perform a titration test to determin the antibody titer with an enzyme cell.This test allows to confirm that the antibody concentration is low and that we are in the limits of detection for the iat techniques.

• 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: 24313203
• Report Number: 9610824-2026-00004
• Device Sequence Number: 12174923
• Product Code: KSZ
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)260209(10)9550011
• Combination Product (Y/N): N
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• 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