MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS

Catalog Number	813112100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that two samples from allegedly one patient showed different blood groups on ih-card abo/d(dvi-)+rev.A1, b when tested on the ih-1000 instrument: on (b)(6) 2023, sample acc # (b)(6) was performed on ih-1000 sn (b)(6) and typed as b rhd negative.On (b)(6)2023, sample acc # (b)(6) was performed on ih-1000 sn (b)(6) and typed as a rhd positive.The customer stated that both samples belonged to the same patient with the same dob (date of birth) and name.The customer did neither provide a sample of the allegedly defective product ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient samples that caused the discrepant results.Therefore, our quality control laboratory tested their retention sample with known donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any discrepancies.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.In addition to the discrepant blood group results the customer complained that the ih-com did not flag the discrepant results.The investigation of the instruments data is still ongoing.Because of the missing information regarding the patient samples in question a more in-depth analysis was not possible.The customer informed us that they were not sure what the correct blood group was supposed to be.The customer believes that the first vial might be mislabeled but does not have that sample available anymore to verify the data.The customer´s concern that the software did not flag the discrepant test results is still under investigation.An initial analysis showed that two samples with different sample numbers were being processed and it was not apparent to the system that the two samples belonged to the same patient.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that two samples from allegedly one patient showed different blood groups on ih-card abo/d(dvi-)+rev.A1, b when tested on the ih-1000 instrument: on (b)(6) 2023, sample acc # (b)(4) was performed on ih-1000 sn (b)(6) and typed as b rhd negative.On (b)(6) 2023, sample acc # (b)(4) was performed on ih-1000 sn (b)(6) and typed as a rhd positive.The customer stated that both samples belonged to the same patient with the same dob (date of birth) and name.The customer did neither provide a sample of the allegedly defective product ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient samples that caused the discrepant results.Therefore, our quality control laboratory tested their retention sample with known donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any discrepancies.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Because of the missing information regarding the patient samples in question a more in-depth analysis was not possible.The customer informed us that they were not sure what the correct blood group was supposed to be.The customer believes that the first vial might be mislabeled but does not have that sample available anymore to verify the data.The customer´s concern that the software did not flag the discrepant test results could be explained as follows: the patient had two different medical record numbers and in one of them the birthday was registered while the other one did not have this information.Therefore, the system behaved as it should and treated this as two separate patients.There was no indication of a malfunction of the device.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
• Common Device Name: IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; instustriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 16982568
• Report Number: 9610824-2023-00021
• Device Sequence Number: 20525997
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)240224(10)9243010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• 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): 06/13/2023

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 Expiration Date: 02/24/2024
• Device Catalogue Number: 813112100
• Device Lot Number: 9243010
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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, (B)(6); IH-1000, (B)(6); IH-1000. (B)(6); IH-1000. (B)(6)
• Patient Sex: Unknown