MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-500 AUTOMATED ANALYZER SYSTEM

Catalog Number	001510
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported discrepant antibody screening results, with suspected low red blood cell dispensing causing an initially weak/negative reaction compared with repeat testing.Reviewed snapshot data, instrument timeline, and customer images for sample (b)(6) on ih-500 sn (b)(6).Initial test showed abnormally low rbc pellet despite correct instrument pipetting volume.Review confirmed the screening cell suspension used for the initial test was non-compliant (insufficient rbc concentration / poor suspension).Repeat testing with a newly loaded reagent kit showed normal pellet formation and expected performance.Additional image analysis with r&d confirmed that the reduced pellet in the original test was at the threshold limit of the low pellet detection algorithm.Since the pellet was borderline and not below the configured threshold, the low pellet alarm was not triggered.The low pellet control is designed to reduce risk of false negative interpretation, but in this case the pellet remained at the detection limit.Based on available evidence, no instrument malfunction was identified; the discrepant result was attributed to reagent handling / non-compliant suspension quality.Resolution: no instrument malfunction identified.Root cause determined to be pre-analytical reagent condition (non-compliant rbc suspension), resulting in insufficient red blood cells being dispensed despite correct volume pipetting and causing discrepant initial test results.
Additional Manufacturer Narrative
This is our initian and final report on this incident.

• Brand Name: IH-500 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-500 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, 63303 ; GM 63303
• MDR Report Key: 25331917
• Report Number: 9610824-2026-00017
• Device Sequence Number: 9806443
• Product Code: KSZ
• UDI-Device Identifier: 07611969233786
• UDI-Public: (01)07611969233786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK230971
• 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): 05/29/2026

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: 001510
• 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: 05/13/2026
• Initial Report FDA Received Date: 05/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IH-CARD AHG ANTI-IGG LOT 9549020.; IH-CELL I-II-III, LOT 9610011, EXP 5/4/26.
• Patient Sex: Unknown