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No common specific root cause or defect was identified.The conclusion(s) code(s) reported herein are assigned according to the facts presented by the affected customer and immucor's assessment and investigation of those facts.When possible, immucor attempts to obtain the actual samples and reagents involved; retention reagents of the same lot that was involved in the event may be used during the investigation if indicated.Also, when possible, immucor uses remote access to review the relevant data archived on the instrument.The events reported on this quarterly malfunction summary report are limited to those in which no patient harm occurred, and no design defect (or other systemic problem) was identified.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.Immucor will continue to track and trend performance and operational issues such as described in this quarterly malfunction summary report.
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A review of quarterly events indicated that for five (5) patient/donor samples tested using the echo lumena automated blood bank system, a malfunction occurred resulting in the instrument producing incorrect results.A review indicated that five (5) patient/donor samples tested using the echo lumena automated blood bank system produced inaccurate results: a abo mistype with anti-a (murine monoclonal) blood grouping reagent for one (1) patient sample; a missed anti-c for one (1) patient sample during an antibody screen; a missed anti-m for one (1) patient sample during an antibody screen; and a missed anti-e for two (2) patient sample during antibody screens.On (b)(6) 2023.A customer received unexpected negative antibody id results on the echo lumena instrument for one patient sample.Negative results were received using capture-r ready id lot number: id458, (expiry december 5, 2023), and capture-r ready id extend ii, lot number: dn144, (expiry october 10, 2023) with capture-r ready indicator cell lot number: 221381, (expiry: october 12, 2023) and capture liss lot number: 211660 on echo lumena instrument serial number (b)(6).The customer subsequently identified an anti-c antibody using their selected peg panels.Patient may be expressing anti-c at or below the level of detection for the assay.Patient is pregnant female aged 42 years; no blood products were transfused.No patient injury or harm was reported.Immucor's investigations using retained products of the same lots did not identify a product deficiency.The immucor internal reference for the associated record is (b)(4).On (b)(6) 2023 a customer received unexpected negative antibody id results on the echo lumena instrument for one patient sample.Negative results were received using capture-r readyid lot number: id459, (expiry december 5, 2023) with capture-r ready indicator cell lot number: 221385 on echo lumena instrument serial number: (b)(6).Patient is female, born (b)(6) 2023; patient has a historic anti-e.No blood products were transfused, and no patient injury or harm was reported.Issue was resolved by switching to capture-r readyid lot number: id460; anti-e was detected with this lot during troubleshooting.On november 1, 2023 an immucor field service engineer (fse) inspected echo lumena instrument serial number:(b)(6) at the customer site.The fse performed the unexpected reaction checklist successfully.No instrument problem was identified.The immucor internal reference for the associated record is (b)(6).On (b)(6) 2023 and (b)(6) 2023 a customer received an unexpected abo typing results on the echo lumena instrument for one patient sample.Customer states instrument reported patient who is historically a neg as o neg using anti-a (murine monoclonal) lot number: 101085e: (expiry april 12, 2025) on echo lumena instrument serial number m20544.Customer repeated the initial sample in tube with same lot of anti-a and received a result of a neg.The patient sample was run 5 times on the echo lumena instrument for the group, three times it resulted as ntd neg and it resulted o neg twice.Patient is female, born (b)(6) 1961 and has a very high white blood cell count.Patient received one platelet transfusion on the way to the customer site; the site that the patient was transferred from also had typing issues-resulting patient as o neg, then changing it to a neg.Patient is positive for a1 lectin and negative for a2 cells.No patient injury or harm was reported.On (b)(6) 2023 immucor used remote access to review the instrument results, the maintenance, camera reports, and event log which showed the reagents and instrument were performing as expected.The issue appears to be sample-related.The immucor internal reference for the associated record is (b)(4).On (b)(6) 2023 a customer received unexpected negative antibody screen results on the echo lumena instrument for one patient sample.Negative results were received using capture-r readyscreen 3, lot number: r534, (expiry december 19, 2023) with capture-r ready indicator cell lot number: 221402 and capture liss lot number: 211671 on echo lumena instrument (b)(4).The patient sample was retested using the same instrument on (b)(6) 2023 and again on (b)(6) 2023; on both occasions the screen results were positive.Patient is male, born 1951 and diagnosed with covid.The patient has a history of anti-m; no transfusions were noted.No patient injury or harm was reported.On november 10, 2023 immucor used remote access to review the instrument results; no errors noted during testing, well fill images appeared acceptable, but final images of initial testing showed a negative cell button with slight adherence and well score of 5 for affected wells.On (b)(6) 2023 an immucor field service engineer (fse) inspected the instrument at the customer site.The fse performed the unexpected reaction checklist successfully.No instrument problem was identified; however, the fse replaced the 1 ml syringe as a precautionary measure.The immucor internal reference for the associated record is: (b)(4).On (b)(6) 2023 a customer received unexpected negative antibody screen results on the echo lumena instrument for one patient sample.Negative results were received using capture-r readyscreen 3 lot number: r534, (expiry: december 19, 2023) with capture-r ready indicator cell lot number: 221450 and capture liss lot number: 211681 on echo lumena instrument (b)(4).Patient has a history of anti-e that was first identified on (b)(6) 2023.No patient injury or harm was reported.Customer repeated the initial sample on both (b)(6) 2023 and (b)(6) 2023 using capture-r readyscreen 3, lot number: r534, (expiry december 19, 2023) with capture-r ready indicator cell lot number: 221429 and capture liss lot number: 211681 on echo lumena instrument s(b)(4) m20376; both repeat screens resulted positive as expected.Patient is female, born (b)(6) 1994, weight 140 kilograms; prenatal patient admitted for placenta previa.Immucor confirmed the presence of the e antigen on retention capture-r readyscreen 3 lot number: r534 and retention capture-r ready indicator cell lot number: 221450 with retention anti-e lot number: 053035.Immucor performed 3_cell assay on the echo lumena using returned patient sample with retention capture-r readyscreen 3, lot number: r534 and retention capture-r ready indicator cell lot number: 221450; the returned sample resulted 2+ with screening cell 2,cells 1 and 3 were negative.Immucor confirmed the presence of the e antigen on the echo lumena using retention capture-r ready screen 3 lot number: r534 cell 2 and the same vial of returned capture-r ready indicator cell lot number: 221450; cell 2 resulted positive for the e antigen as expected.Immucor performed 3_cell assay on the echo lumena using an igg source of anti-e with retention capture-r ready-screen 3, lot number: r534 and a second vial of returned capture-r ready indicator cell lot number 221450; the anti-e sample resulted 4+ with screening cell 2 (cells 1 and 3 were negative as expected).Immucor performed 3_cell assay on the echo lumena using an igg source of anti-e with retention capture-r ready-screen 3 lot number: r534 and a third vial of returned capture-r ready indicator cell lot number: 221450; the anti-e sample resulted 4+ with screening cell 2 (cells 1 and 3 were negative as expected).Our investigation did not identify a product deficiency.The immucor internal reference for the associated record is (b)(4).
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