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

Model Number	001510
Medical Device Problem Codes	False Positive Result (1227); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer processed a patient sample with ih-card abo/d(dvi-)+rev.A1, b on ih-500.The customer reported that a dp (double population, mixed field) reaction was not recognized as such but was evaluated as a 2+ positive reaction by the instrument.The customer did neither provide the allegedly defective product sample ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient sample.Therefore, our quality control laboratory tested "theit" retention sample of the supposedly defective lot with donor samples on ih-500.Various weak d red blood cell samples were also part of the tests.All results were correct and were also interpreted correctly by the software.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.An investigation of the affected ih-500 data is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer processed a patient sample with ih-card abo/d(dvi-)+rev.A1, b on ih-500.The customer reported that a dp (double population, mixed field) reaction was not recognized as such but was evaluated as a 2+ positive reaction by the instrument.The customer did neither provide the allegedly defective product sample ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient sample.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot with donor samples on ih-500.Various weak d red blood cell samples were also part of the tests.All results were correct and were also interpreted correctly by the software.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The daily journal and trace files of the affected instrument ih-500 were provided and analyzed.This investigation did not show any indication of a malfunction of the device.The provided material showed that visually, both wells look similar, but the algorithm of the instrument identified some agglutinations in the middle of the wells.It is known that pixels identified at different well zones could affect the interpretation by the instrument.Also, the wells are borderline of the ih-card image interpretation.Based on the investigation of the instrument data the complaint was classified as confirmed - epp (expected product performance).In the reaction that was rated as 2+, there were some small agglutinates in the middle, so the reaction was not rated as dp but as 2+ by the software.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: IH-500
• Common Device Name: IH-500
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 13583550
• Report Number: 9610824-2022-00010
• Device Sequence Number: 17547544
• Product Code: KSZ
• UDI-Device Identifier: 07611969233786
• UDI-Public: (01)07611969233786
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK180274
• 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): 03/23/2022

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 Model Number: 001510
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/23/2022
• 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 ABO/D(DVI-)+REV A1,B LOT: 9138010; IH-CARD ABO/D(DVI-)+REV A1,B LOT: 9138010
• Patient Sex: Unknown