The customer processed a patient sample with ih-card abo/d(dvi-)+rev.A1, b on ih-500.The customer reported that a dp (double population, mixed field) reaction was not recognized as such but was evaluated as a 2+ positive reaction by the instrument.The customer did neither provide the allegedly defective product sample ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient sample.Therefore, our quality control laboratory tested "theit" retention sample of the supposedly defective lot with donor samples on ih-500.Various weak d red blood cell samples were also part of the tests.All results were correct and were also interpreted correctly by the software.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.An investigation of the affected ih-500 data is still ongoing.
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The customer processed a patient sample with ih-card abo/d(dvi-)+rev.A1, b on ih-500.The customer reported that a dp (double population, mixed field) reaction was not recognized as such but was evaluated as a 2+ positive reaction by the instrument.The customer did neither provide the allegedly defective product sample ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient sample.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot with donor samples on ih-500.Various weak d red blood cell samples were also part of the tests.All results were correct and were also interpreted correctly by the software.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The daily journal and trace files of the affected instrument ih-500 were provided and analyzed.This investigation did not show any indication of a malfunction of the device.The provided material showed that visually, both wells look similar, but the algorithm of the instrument identified some agglutinations in the middle of the wells.It is known that pixels identified at different well zones could affect the interpretation by the instrument.Also, the wells are borderline of the ih-card image interpretation.Based on the investigation of the instrument data the complaint was classified as confirmed - epp (expected product performance).In the reaction that was rated as 2+, there were some small agglutinates in the middle, so the reaction was not rated as dp but as 2+ by the software.
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