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

Model Number	5.0.10
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported atypical results of one patient.The customer provided two daily journal images of type and screen using ih-1000 on the same patient.Two samples were collected approximately a week apart with similar results.The back type and the antibody screen reactions were clearly atypical.The software ih-com, version 5.0 interpreted these results as negative, and there are very clearly not negative, but although clearly not typical positive either.In both cases the abo/rh was ntd (not to determine) due to forward reverse mismatch.The results were corrected by the user but the results were flagged not for the reason they should have been.The patient has a history of multiple myeloma and the examples were expected to present with atypical results.The investigation is still ongoing.
Event or Problem Description
The customer reported atypical results of one patient.The customer provided two daily journal images of type and screen using ih-1000 on the same patient.Two samples were collected approximately a week apart with similar results.The back type and the antibody screen reactions were clearly atypical.The software ih-com, version 5.0 interpreted these results as negative, and there are very clearly not negative, but although clearly not typical positive either.In both cases the abo/rh was ntd (not to determine) due to forward reverse mismatch.The results were corrected by the user but the results were flagged not for the reason they should have been.The patient has a history of multiple myeloma and the examples were expected to present with atypical results.Our investigation confirmed that all tests were correctly performed by the instrument and no issue or malfunction on the instrument was identified (from the trace files analyses) and the wells a1 and b were interpreted as negative.According to the analysis our technician conducted the detection of the double population on the reverse group and the ab screening test was deactivated.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: IH-COM
• Common Device Name: IH-COM
• 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: 9115079
• Report Number: 9610824-2019-00053
• Device Sequence Number: 11393920
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK180275
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 5.0.10
• Device Catalogue Number: 009101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 02/21/2023
• 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-1000, # 5100073; IH-1000, # 5100073; IH-CARD ABO/D(DVI-)+REV A1,B, # 8903080; IH-CARD ABO/D(DVI-)+REV A1,B, # 8903080; IH-CARD AHG ANTI-IGG, # 88500070; IH-CARD AHG ANTI-IGG, # 88500070; IH-CELL A1&B, # 8927011; IH-CELL A1&B, # 8927011; IH-CELL I-II-III, # 8927011; IH-CELL I-II-III, # 8927011
• Patient Sex: Unknown