MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD RH-PHENOTYPE+K; IH-CARD RH-PHENOTYPE+K; 48 CARDS

Catalog Number	813201100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false positive reactions with the anti-e of ih-card rh-phenotype+k when used on ih-1000.The customer stated that the reactions were called 1+ positive by the instrument, but were visually negative.The customer did neither return the complaint sample ih-card rh-phenotype+k for investigational testing nor the control that caused the false positive test results.Therefore our quality control laboratory (qc) tested their retention sample of the supposedly defective lot with different donor samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The investigation of the affected ih-1000 is still ongoing.
Event or Problem Description
The customer reported false positive reactions with the anti-e of ih-card rh-phenotype+k when used on ih-1000.The customer stated that the reactions were called 1+ positive by the instrument, but were visually negative.The customer observed this issue when using cell #2 of biotestcell 3 as a control.The customer did neither return the complaint sample ih-card rh-phenotype+k for investigational testing nor the control that caused the false positive test results.Therefore our quality control laboratory (qc) tested their retention sample of the supposedly defective lot.Our quality control laboratory visually inspected their retention sample for intact sealing, homogeneous gel, visible supernatant, and the absence of splashes in the reaction chamber.All acceptance criteria were met.Then our quality control laboratory tested the retention sample of the supposedly defective lot with different donor samples and controls on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction or question mark results.Furthermore the ih-card rh-phenotype+k was tested with biotestcell 3.An original vial of cell #2 (ee, e antigen negative) of biotestcell 3 was centrifuged and the centrifuged reagent red blood cells were used unwashed and washed (two times with isotonic saline) for the preparation of the red blood cell suspension.The reactions were visually assessed clearly negative, but ih-1000 rated them as question mark.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Based on the investigation the complaint was classified as undetermined.The complaint sample was not available, and the retention sample reacted as expected.Within our investigation our quality control laboratory only observed question mark results when we used biotestcell 3 as the customer did.We would like to point out that the intended use of biotestcell 3 is the tube test and the solid phase test solidscreen, but not the ih-system.Based on our investigation we cannot exclude that the observed issue was caused by use of biotestcell 3.Therefore, we highly recommend not using biotestcell 3 in the ih-system.Images and files of the affected instrument ih-1000 were analyzed.The analysis of the provided data showed that the reading module and camera were correctly adjusted.
Additional Manufacturer Narrative
This is our final report ont his incident.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD RH-PHENOTYPE+K
• Common Device Name: IH-CARD RH-PHENOTYPE+K; 48 CARDS
• 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: 11492369
• Report Number: 9610824-2021-00012
• Device Sequence Number: 2776635
• Product Code: QHR
• UDI-Device Identifier: 07611969952144
• UDI-Public: (01)07611969952144(17)210911(10)8020010
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/23/2023

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: 09/11/2021
• Device Catalogue Number: 813201100
• Device Lot Number: 8020010
• 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: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 02/23/2023
• 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, # 5100081.; IH-1000, # 5100081.
• Patient Sex: Unknown