MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number	001100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial and final report on this incident.
Event or Problem Description
The customer reported a false positive reaction during patient antibody screening when a sample was tested in the same batch as another sample from a patient receiving anti-cd38 therapy.- additional information: the customer confirmed that sample (b)(6) belongs to the patient with anti-cd38.- daily journal review: the sample showed in antibody screening test strong reactions interpreted 1+.The other sample (b)(6) showed in antibody screening test weaker reactions interpreted 1+ as well.- traces files analysis: review of the complete workflow shows that the pipetting needle sequentially accessed tubes (b)(6), then again (b)(6), followed by (b)(6).Given this sequence, there is a credible risk of carry-] over.Specifically, sample (b)(6) may have been contaminated during the antibody screening process after the needle previously aspirated material from sample (b)(6) during the forward grouping test.This sequence constitutes a plausible technical explanation for the observed findings and should be considered a likely contributing factor in the investigation.Resolution: there is the "faq anti-cd38 samples testing on instruments" document available in the ih-area.It provides explanation and advice regarding the handling of samples from patients having anti-cd38 treatment.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: monica albarca aguilera ; industriestrasse 1; dreieich, ; GM
• MDR Report Key: 25021759
• Report Number: 9610824-2026-00016
• Device Sequence Number: 18538616
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• 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
• Report Date (Section B): 04/28/2026

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 Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/28/2026
• 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-CELL I-II, LOT 9606011.
• Patient Sex: Unknown