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	11/23/2020
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 that the blood group of six patient samples failed on tango optimo.The results failed because of so called "globs" in the reverse typing.The customer stated that this issue occurred with erytype s abd +rev a1b and erytypecell a1 and due to the globs the reaction were evaluated as positives.The images provided by the customer showed that the negative reactions with erytypecell a1 were not completely resuspended and therefore as positive reactions rated.Because the customer did not provide the complaint sample, our quality control laboratory tested their retention sample with different donor samples on tango optimo.All positive and negative reactions were correct.We did not observe any incompletely resuspended negative reactions.The customer provided result images that show an artifact in the a1 cell of reverse typing, which leads the instruments result interpretation software to calculate a positive result (2+) instead of a negative following a discrepancy between forward and reverse typing.The discrepancy is visible to the customer by showing up the discrepancy flag and question marks in the overall result field.No false result was shown by the instrument.A service engineer was not dispatched, because the issue was seen only with a few boxes of erytype plates that went wet and testing with other boxes resulted as expected on following days.The cause for wet boxes remained unknown.The log files of the affected instrument did not show any issue relevant abnormalities.Based on our investigation the complaint is classified as undetermined.The complaint sample was not available for investigation and the retention sample reacted as expected.The customer observed that her two erytype boxes were received wet.Because the wet boxes were not provided for investigation, the root cause of the not completely resuspended negative reactions observed by the customer remained unknown.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective product lot.From the instrument's perspective, based on current information and data there is no indication for an instrument malfunction.The customer confirmed a proper function of the instrument.

• 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
• MDR Report Key: 11018553
• Report Number: 9610824-2020-00090
• Device Sequence Number: 4496391
• Product Code: QHR
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)211107(10)8020030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 11/07/2021
• Device Catalogue Number: 806127100
• Device Lot Number: 8020030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1