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	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial 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.In ih-com, the first 2 digits of the customer number is for the year (i.E., 21=2021; 22=2022, etc.).The customer erroneously selected a patient from (b)(6) 2021 instead of (b)(6) 2022 (same id number except for the "22" in front of the number), and the original image well results were still present.The result was released before it was noticed, and the actual patient ((b)(6) 2022) was a different blood type.The customer had to process a corrected report.The customer was questioning when the original images disappear and are replaced by a "rendering" or a picture representation.Ih-com data files were received for investigation but were corrupt.For this reason, we couldn't yet analyze the customer specific data base yet.But generally in ih-com one has the possibility to "reopen verified or validated tests".This is only possible by a user with the rights 90 or higher (ih-com administrators).The option "resend" will send a result again to the host/lis.This may lead to an issue as the lis the customer is using is not taking the first two digits of the sample barcode into account.The first 2 digits of the bar code the customer is using is for the year (i.E., 21=2021; 22=2022, etc.).This option is available for normal users (rights 50).We are still waiting for ih-com data files that are not corrupt to investigate if a malfunction of the software is present.
Additional Manufacturer Narrative
This is our 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.In ih-com, the first 2 digits of the customer number is for the year (i.E., 21=2021; 22=2022, etc.).The customer erroneously selected a patient from 02021 instead of 06/23/2022 (same id number except for the "22" in front of the number), and the original image well results were still present.The result was released before it was noticed, and the actual patient ((b)(6) 2022) was a different blood type.The customer had to process a corrected report.The customer was questioning when the original images disappear and are replaced by a "rendering" or a picture representation.Ih-com data files were received for investigaion but were corrupt.For this reason, we couldn't yet analyze the customer specific data base yet.But generally in ih-com one has the possibility to "reopen verified or validated tests".This is only possible by a user with the rights 90 or higher (ih-com administrators).The option "resend" will send a result again to the host/lis.This may lead to an issue as the lis the customer is using is not taking the first two digits of the sample barcode into account.The first 2 digits of the bar code the customer is using is for the year (i.E., 21=2021; 22=2022, etc.).This option is available for normal users (rights 50).A new data base was collected for investigation.The data base does not show any traces that the sample in question has been revalidated.This information would stay in the data base without any limitation.Our investgation team searched the concerned time range for similar entries but couldn't find any.This means that the user most probably used the manual "send result" function.This is traced as well but this information (message in black) will be deleted after 7 days and is therefore no more available in the traces/data base that our team have received for analysis.It is most likely that the user has used the function "send result".The result has been sent again to the lis, but has been interpreted in a wrong way as it ignores the first two digits which represent the year.No issue in ih-com has been identified.All the involved functions worked as expected.

• 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: 15091568
• Report Number: 9610824-2022-00037
• Device Sequence Number: 12052142
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 08/02/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-1000, SN (B)(6).
• Patient Sex: Unknown