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

Model Number	814172100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a weak d positive control was interpreted as d negative by the ih-reader 24 with ih-internal qc, lot 51986200093 used as control.When the customer scanned sample 4 from the ih-internal qc kit for the weak d control sample into "control sample", the rh typing was populated with a "rh d weak" as result.When sample 4 was run for the weak d positive control, the tech forgot to add anti-d blend thus getting a negative result.Even though the result was negative and the ih-reader 24 interpreted the result as "d negative," the system marked the qc as being passed.Testing of the affected ih-internal qc in our quality laboratory is still ongoing.Investigation of the affected ih-reader 24 is also still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.Our initial report on this incident was issued for the ih-internal qc but our investigation showed that the issue was caused by a software bug of the ih-com v5.0.So we amended this follow-up/final report accordingly.
Event or Problem Description
The customer reported that they ran ih-internal qc sample 4 for the weak d positive control, but the tech forgot to add anti-d blend thus getting a negative result.Even though the result was negative and the ih-reader 24 interpreted the result as "d negative," the system marked the qc as being passed.The customer had to change the "rh d weak" to "rh d positive" for the system to interpret the weak d qc correctly.The qc settings on the provided print screens were correct.Print screens pictures and support backup do not allow to confirm these settings as being the one configured now of qc sample processing due to no date and time on the print screen pictures.Furthermore, the support backup (provided from october 30th) was taken more than 7 days after the issue has occurred (september 15th).Therefore, only truncated log data were available.We could confirm that the rhd weak interpretation is not properly compared to the rhd result interpretation when no "required reactions" are set when using the current validated ih-com version v5.0.9 or v5.0.10.However, this issue is being solved within the introduction of the upcoming ih-com version.The advice for the user for a workaround, until the new ih-com version became available, was to use the "required reaction" setting for "rhd weak" sample in the "control test" section so that only the acceptable well reactions do allow to obtain a valid qc status.If only the test specific target reaction strengths +/-, +, ++, +++ und ++++ are selected the qc will be graded as failed in case of a negative reaction.For further information the customer was advised to consulate the ih-com user manual under the section "quality control".The complaint was classified as confirmed - upp (unexpected product performance).The root cause of the complaint issue was identified as a bug in the software ih-com v5.0 and addressed.The bug was solved in the software version ih-com v5.2.5.The software ih-com v5.2.5 was released on march 15, 2021.

• 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
• MDR Report Key: 10710000
• Report Number: 9610824-2020-00072
• Device Sequence Number: 1009662
• Product Code: KSZ
• UDI-Device Identifier: 07611969952342
• UDI-Public: (01)07611969952342(17)200921(10)51986200093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: 09/21/2020
• Device Model Number: 814172100
• Device Catalogue Number: 009101
• Device Lot Number: 51986200093
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH READER 24, # 146011005; IH READER 24, # 146011005; IH-INTERNAL QC, LOT 780200093; IH READER 24, # 146011005