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

Catalog Number	806127100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false negative result of a patient sample with the anti-b of erytype s abd+rev.A1, b when used on tango infinity.The customer stated that the reaction looked like mixed field.The customer provided the complaint sample and also the patient sample for investigational testing.Our quality control laboratory tested the complaint sample with donor samples and the patient sample provided by the customer on tango infinity.The donor samples showed correctly positive and negative reactions.The patient sample could not be correctly evaluated by the tango instrument because the amount of pipetted red blood cells was insufficient.A repeat testing was not possible, because the complaint sample was used up.Our quality control laboratory had tested the same donor samples and the patient sample with the retention sample of the supposedly defective lot on tango infinity.Again, the donor samples showed the correct positive and negative reactions.The patient sample showed a very small agglutinate with the anti-b which was assessed as negative by the instrument.Additionally, the patient sample was tested with seraclone anti-b in the tube test (immediate spin) and showed a negative result.Furthermore, the patient sample was tested in the gel card.The patient sample showed double population with antia and anti-ab.The patient sample showed only a few small agglutinates with the anti-b on top of the gel column and a pellet at the bottom.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The customer provided a result image that shows a mixed field reaction in the anti-b well.Because the whole background was dark red colored, the result was interpreted as a negative reaction by the instruments software of image evaluation.No overall result was given by instruments software as there was a discrepancy discovered.The last preventative maintenance was conducted on may 21, 2021.A field service engineer checked the affected tango infinity.He collected log files and databases.He checked the instrument function and camera settings.He also performed metrology within specifications.The instrument was confirmed to be operating within manufacturer specification and returned to full operation.Metrology qualification was performed with passing all the significant checks and qc.The log files did not show any issue relevant abnormalities.From instrument's perspective, based on current information and data there is no indication for an instrument malfunction.The qc passed at the day of issue.No false result was released because the discrepancy was identified by the instruments software.Furthermore, customer may refer to the user manual's statement: "mixed field reaction can lead to an erroneous result with automated analysis of erytype s assays." the field service engineer confirmed that the instrument is working within specification based on the images provided by customer and the investigation the complaint was classified as confirmed - epp (expected product performance).The complaint and the retention sample reacted as expected.Only the patient sample showed a mixed field reaction which was assessed as a negative reaction by the tango instrument.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.(b)(4).

• 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 (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: 12967449
• Report Number: 9610824-2021-00080
• Device Sequence Number: 17256217
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)220501(10)8045010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/09/2021

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: 05/01/2022
• Device Catalogue Number: 806127100
• Device Lot Number: 8045010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, (B)(4)
• Patient Sex: Unknown