MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL I-II; IH-CELL I-II, 2 X 10 ML

Catalog Number	814050100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a negative result with our product ih-cell i-ii for two tests of the same patient.One test was performed on (b)(6) 2023 and the second test was perfomred on (b)(6) 2025 and the test results were negative each time.Another facility detected an anti-c.The patient had no known transfusion history.The customer reported both cases on august 11, 2025.While he was able to provide information on the product used for the test performed in (b)(6) 2025, he was not able to provide such information on the product used in the test back in 2023.Also, it was not possible to retrieve data from the ih-1000 used for testing.For this reason, we refrain from submitting a report for the incident in (b)(6) 2023.Regarding the allegedly false negative test result obtained in (b)(6) 2025, the customer did not provide a patient sample for investigational testing in our quality control laboratory.The customer filed his complaint in august 2025, when the allegedly defective lot of ih-cell i-ii has alreday been expired six weeks ago, therefore, no tests could be carried out.A review of our batch record has not shown any abnormalities that could have negatively affected product quality.The qc daily journal from the date of event was checked and showed that all qc was acceptable.The allegedly false negative test result is suspected to be related to a paitent sample problem.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL I-II
• Common Device Name: IH-CELL I-II, 2 X 10 ML
• 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: 22990137
• Report Number: 9610824-2025-00031
• Device Sequence Number: 9089728
• Product Code: QHT
• UDI-Device Identifier: 07611969952274
• UDI-Public: (01)07611969952274(17)250602(10)9514011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/08/2025

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: 06/02/2025
• Device Catalogue Number: 814050100
• Device Lot Number: 9514011
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• 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-CARD AHG ANTI-IGG, LOT 9444010
• Patient Sex: Unknown