MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-COM V5.0

Model Number	5.0.10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
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 that ih-com on the ih-1000 instrument assigned an incorrect test result to a patient.One sample (no.(b)(6)) was processed on the ih-1000 instrument on (b)(6) 2018 on one patient.The same sample number (b)(6) was reused on (b)(6) 2022 for a different patient.The patient data are properly managed and assigned.In ih-com, samples are handled fully separately as visible on the printscreens that were provided for investigation.Ih-com consequently could not sent the wrong results to the lis with an automatic result sending to lis after result validation.Visible in the support backup is that a user sends results manually to the lis and sends two results of the same sample number.In the lis data, sample and patient data are always visible but here, lis considered only the sample number and not the patient data causing a mix-up in the lis.By reviewing the lis files, in fact the user sent twice the results of sample (b)(6) for the sample processed in 2018.Ih-com sent properly the data associated with the patient data from 2018.The root cause of the reported issue has a combination of two issues: handling issue: user sent manually to the lis the results from 2018 instead the one from the sample processed in 2022, and lis issue: lis just referred to the sample number to integrate the results.Consequently, the lis associated the old results from old patient of 2018 wrongly to the new patient 2022.Here the issue is related to user handling and the laboratory information system.Ih-com is working inside specification.

• Brand Name: IH-COM V5.0
• Common Device Name: IH-COM V5.0
• 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: 15713758
• Report Number: 9610824-2022-00068
• Device Sequence Number: 4800968
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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: 5.0.10
• Device Catalogue Number: 009101
• 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: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• 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-1000, SN 5100025
• Patient Sex: Unknown