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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 galileo echo v2.0 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 galileo echo v2.0 automated blood bank system produced inaccurate results: missed anti-e during an antibody screen for two (2) patient samples; missed anti-s during an antibody screen for one (1) patient sample; unexpected d positive for one (1) donor; and missed anti-d during an antibody screen for one (1) patient sample.On october 18, 2023 a customer received unexpected negative antibody screen results on the galileo echo v2.0 instrument for one patient sample.Negative results were received using capture-r ready-screen 3 lot number r527 (expiry november 21, 2023) and capture-r ready-id extend1 lot number dp136 (expiry december 5, 2023) with capture-r ready indicator cell lot number 221392 on galileo echo v2.0 instrument serial number (b)(6).Patient is male, born (b)(6)1955 with a gi bleed and a history of anti-e.No transfusion history was provided and no patient injury or harm was reported.Customer repeated on bench with panocell 10 (1+ results); anti-e identified.On october 20, 2023 immucor used remote access to review the review images of the affected plates; no issue were noted.On (b)(6) 2023 immucor confirmed the presence of the e antigen on cell 2 of retention capture-r ready-screen 3 lot number r527 using anti-e lot number 22012712 with retention capture-r ready indicator cell lot number 221392; controls performed as expected, and cell 2 resulted positive for the e antigen as expected and capture-r ready indicator cell lot number 221392 was able to detect antibody.On (b)(6) 2023 immucor confirmed the presence of the e antigen cells 8 - 14 of retention capture-r ready-id extend 1 lot number dp136 using anti-e lot number 22012712 with retention capture-r ready indicator cell lot number 221392; controls performed as expected, and cells 8 - 14 resulted positive for the e antigen as expected and capture-r ready indicator cell lot number 221392 was able to detect antibody.Retention products performed as expected.The immucor internal reference for the associated record is pr#(b)(6).On october 2, 2023 a customer received unexpected negative antibody screen results on the galileo echo v2.0 instrument for one patient sample.Negative results were received using capture-r ready-screen 3 lot number r532 (expiry december 5, 2023) with capture-r ready indicator cell lot number 221382 and capture liss lot number 211665 on galileo echo v2.0 instrument serial number (b)(6).Patient is male, age 58 years; no additional patient information was provided.No patient injury or harm was reported.Customer found anti-e in the tube with peg testing; reaction was 2+ in the tube with peg.Customer repeated the sample on (b)(6) 2023 on the galileo echo v2.0 instrument; this repeat testing resulted as negative for the 3 cell screen.On (b)(6), 2023 immucor confirmed the e antigen on all e positive cells (cell 2) of retention capture-r ready-screen 3 lot number r532 by capture method using retention anti-e lot number 053035 and retention capture-r ready indicator cell lot number lot number 221393.Controls performed as expected.All e positive cells (cell 2) resulted positive with retention anti-e; all cells resulted as expected.The immucor internal reference for the associated record is pr#(b)(6).On november 7, 2023 a customer received unexpected negative antibody screen results on the galileo echo v2.0 instrument for one patient sample.Negative results were received using capture-r ready-screen 3 lot number r531 (expiry december 5, 2023), capture-r ready-id lot number id459 (expiry december 5, 2023) and capture-r ready-id extend 1 lot number dp136 (expiry december 5, 2023) with capture-r ready indicator cell lot number 221398 on galileo echo v2.0 instrument serial number (b)(6).Customer found anti-s in the tube with peg testing; reaction was 1+.Patient is female, age 55 years with viral infection and anemia; no additional patient information was provided.No patient injury or harm was reported.On november 22, 2023 an immucor field service engineer (fse) inspected the instrument at the customer site; no instrument problem was noted.The immucor internal reference for the associated record is pr#(b)(6).On december 2, 2023 a customer reported that they received an unexpected abo typing results on the galileo echo v2.0 instrument for one donor sample.Customer states that sample from a donor who is historically a neg was reported as a pos using anti-d monoclonal ser 4 lot number 504058e (expiry february 22, 2025) on galileo echo v2.0 instrument serial number (b)(6).On december 6, 2023 immucor used remote access to review the affected results; no errors or problems were found, but sample resulted 3+ for anti-d monoclonal series 4 (no anti-d monoclonal series 5 was used).Customer repeated abo assay on december 6, 2023 using anti-d monoclonal series 4 and anti-d monoclonal series 5 which resulted a neg as expected.On december 7, 2023 immucor performed a group assay on the echo lumena using 4 in house donor samples with known aborh types (testing included the use of retention anti-d mono series 4 lot number 504058e and retention cmt plate lot number nu020); controls performed as expected, and all in house samples resulted as expected for their respective aborh type.No patient injury or harm was reported.The immucor internal reference for the associated record is pr# (b)(6).On december 18, 2023 a customer received unexpected negative antibody screen results on the galileo echo v2.0 instrument for one patient sample.Negative results were received using capture-r ready-screen 3 lot number r542 (expiry january 16, 2024) with capture-r ready indicator cell lot number 221450 on galileo echo v2.0 instrument serial number (b)(6).No transfusion resulted from this testing, and no patient injury or harm was reported.An antibody screen for this patient was repeated twice on (b)(6) 2023 using the same instrument and reagents; the first result was equivocal and the second result was positive (1+).On december 21, 2023 the customer used capture-r deady-id lot number id461 (expiry january 30, 2024) and capture-r deady-id extend 1 lot number dn146 (expiry january 30, 2024) with capture-r ready indicator cell lot number 221450 on neo iris instrument to identify presence of an anti-d.Patient is female age 81 years, born (b)(6) 1942 admitted for pylori infection, diabetes, hyperbilirubinemia; no transfusions at customer facility since december 18, 2023 (no other patient information was provided).Immucor is unable to rule out a sample-related issue due to low concentration of antibody present.The immucor internal reference for the associated record is pr#(b)(6).
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