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

Catalog Number	814080100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
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 wanted to load ih-panel 11 papain on his ih-500 and noticed in cells 7 and 2 small clumps or threads.Therefore, no testing could be performed and the customer suspected a possible contamination.The customer sent in the allegedly defective product for investigational testing.All vials provided by the customer were leaked out as no drop pipettes were used for sealing of the opened vials.Therefore our quality control laboratory tested their retention sample of the affected lot.The cells were resuspend and it was investigated if a proper re-suspension is given or if strands of cells are visible.Afterwards the filling volume on the ih-500 was measured.The retention sample was also visually inspected.When carefully mixed, no small clumps or threads were visible.The suspensions were without abnormalities.

• Brand Name: REAGENT RED BLOOD CELLS IH-PANEL 11 PAPAIN
• Common Device Name: IH-PANEL 11 PAPAIN; 11X4 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: 21717927
• Report Number: 9610824-2025-00010
• Device Sequence Number: 21320246
• Product Code: KSZ
• UDI-Device Identifier: 07611969952304
• UDI-Public: (01)07611969952304(17)250315(10)9503011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/28/2025

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: 03/17/2025
• Device Catalogue Number: 814080100
• Device Lot Number: 9503011
• 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: 03/08/2025
• Initial Report FDA Received Date: 03/28/2025
• 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
• Patient Sex: Unknown