MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B

Catalog Number	806127100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported an unexpected weak positive reaction of one patient sample with the anti-d (clone 232) of erytype s abd+rev.A1, b on tango infinity.The customer provided images of the tango infinity which showed a weak positive reaction with the anti-d 232, while the reaction with anti-d 226 was negative.The customer did neither provide the complaint sample of erytype s abd+rev.A1, b for investgational testing nor the patient sample that caused the reaction in question.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on the tango infinity.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 tango infinity instrument is still ongoing.
Event or Problem Description
The customer reported an unexpected weak positive reaction of one patient sample with the anti-d (clone 232) of erytype s abd+rev.A1, b on tango infinity.The customer provided images of the tango infinity which showed a weak positive reaction with the anti-d 232, while the reaction with anti-d 226 was negative.The customer did neither provide the complaint sample of erytype s abd+rev.A1, b for investgational testing nor the patient sample that caused the reaction in question.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on the tango infinity.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 tango infinity instrument showed no indication for a malfunction of the instrument.Reviewed were the field service report // field service notes and metrology certificate and further received relevant information.Also, the data bases and the instrument's log files were reviewed for any issue relevant anomalies.A statistical analysis was performed for over 360 days of processing the erytype abd+rev a1,b assay.Approximately 7600 samples were processed during this period, in total only 3 results with a positive and a negative d evaluation could be found, two of them concerning the sample in focus of this report.The tango images do not show any abnormalities.The ratings are locigal.Some variations in the rating are normal and are within the range, especially with weak positive reactions slightly different ratings can occur as for example with the reactions of weak d red blood cells in the two anti-d clones bs226 and bs232.Besides the sample (b)(6), no other discrepant samples were found.Based on the investigation the complaint was classified as undetermined: the complaint sample was not available for investigation and the retention sample reacted as expected.The patient sample in question was not available for further investigation.Nevertheless, we referred to the section limitation of the instruction for use: "samples with a positive direct antiglobulin test, cold agglutinins, or rouleaux formation may show false positive results in testing with monoclonal antibodies.Results on these samples must be interpreted with caution.False positive results or reaction suspected to be due to cold agglutinins should be resolved according to in -house procedures." the investigation of the instrument data does not show any hints for a device malfunction, analysis of all available abd rev a1,b assay results did not show any other discrepant result.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 17582698
• Report Number: 9610824-2023-00043
• Device Sequence Number: 5045369
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)240218(10)9234020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 125094
• 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): 08/24/2023

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: 02/18/2024
• Device Catalogue Number: 806127100
• Device Lot Number: 9234020
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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: TANGO INFINITY, SN (B)(6) ; TANGO INFINITY, SN (B)(6)
• Patient Sex: Unknown