Echo Lumena 0086998Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10888234002338), received between Oct 2, 2018 and Apr 30, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (41 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR EIGHTEEN (18) TEST EVENTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046556 ↗
• MalfunctionMar 22, 2026Protective Measures Problem

  ON FEBRUARY 20, 2026 A CUSTOMER REPORTED THAT TECHNICIAN WAS INJURED WHILE REPLACING THE SYRINGE OF ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER HAS STATED THAT THE EVENT WAS REPORTED FOR DOCUMENTATION PURPOSES ONLY.

  Patient problems: Pain

  MAUDE report 24658804 ↗
• MalfunctionMar 13, 2026False Negative Result

  ON (B)(6) 2026 A CUSTOMER REPORTED UNEXPECTED CROSSMATCH RESULTS ON THE ECHO LUMENA INSTRUMENT.

  Patient problems: Transfusion Reaction

  MAUDE report 24599512 ↗
• MalfunctionJan 29, 2026False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR SEVENTEEN (17) TEST EVENTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218842 ↗
• MalfunctionOct 31, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR NINETEEN (19) TEST EVENTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442467 ↗
• MalfunctionJul 23, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR TWENTY-ONE (21) TEST EVENTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573448 ↗
• MalfunctionFeb 12, 2025Computer Software Problem; Computer Software Problem

  ON JANUARY 17, 2025 IMMUCOR ISSUED A PRODUCT NOTIFICATION TO INITIATE REMOVAL OF INSTRUMENT SOFTWARE VERSION 2.2.0.55 WHICH HAD BEEN RECENTLY INSTALLED ON CERTAIN ECHO LUMENA AND GALILEO ECHO (V2.0) INSTRUMENTS (NO FOREIGN INSTALLATIONS WERE AFFECTED BECAUSE SOFTWARE VERSION 2.2.0.55 HAD ONLY BEEN INSTALLED ON A LIMITED NUMBER OF US INSTRUMENTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368510 ↗
• MalfunctionJan 31, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED 16 EVENTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287471 ↗
• MalfunctionNov 5, 2024False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR TWELVE (12) 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 NINE (9) PATIENT SAMPLES AND THREE (3) DONOR SAMPLES TESTED USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-C AND ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-FYA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-FYA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-JSA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-FYA AND ANTI-KELL FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-KELL FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED UNSPECIFIED ANTIBODY FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-JKA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN AND ANTIBODY ID; A MISSED ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN AND ANTIBODY ID; AND UNEXPECTED ABO TYPING RESULTS FOR THREE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611248 ↗
• MalfunctionOct 31, 2024False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR TWELVE (12) 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 NINE (9) PATIENT SAMPLES AND THREE (3) DONOR SAMPLES TESTED USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-C AND ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-FYA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-FYA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-JSA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-FYA AND ANTI-KELL FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-KELL FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED UNSPECIFIED ANTIBODY FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN; A MISSED ANTI-JKA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN AND ANTIBODY ID; A MISSED ANTI-E FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY SCREEN AND ANTIBODY ID; AND UNEXPECTED ABO TYPING RESULTS FOR THREE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579146 ↗
• MalfunctionApr 29, 2024False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR SIX (6) 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 SIX (6) PATIENT/DONOR SAMPLES TESTED USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: AN ABO MISTYPE WITH FOR THREE (3) PATIENT SAMPLES; A MISSED ANTI-C FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; A MISSED ANTI-JKA FOR ONE (1) PATIENT SAMPLE DURING AN ANTIBODY ID; AND A MISSED ANTI-E FOR ONE (1) PATIENT SAMPLE DURING ANTIBODY SCREEN. ON DECEMBER 27, 2023 A CUSTOMER REPORTED THAT THEY RECEIVED AN UNEXPECTED ABO TYPING RESULTS ON THE ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6) FOR ONE CORD BLOOD SAMPLE. CUSTOMER STATES THAT ON NOVEMBER 11, 2023 A BABY TYPED AS B POS ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6). WHEN A NEW SAMPLE FROM THE SAME BABY WAS TESTED IN TUBE METHODOLOGY ON DECEMBER 26, 2023 IT RESULTED AS AB POS. BABY RECEIVED NO TRANSFUSIONS PER CUSTOMER. CUSTOMER STATES THAT THE SAMPLE RAN ON DECEMBER 26, 2023 IN TUBE METHODOLOGY HAD A WEAK 1+ REACTION WITH ANTI-A IN TUBE AND ANTI-B AND ANTI-D4 WERE 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209182 ↗
• MalfunctionJan 30, 2024False Negative Result; False Negative Result

  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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611535 ↗
• MalfunctionOct 18, 2023False Negative Result; False Negative Result

  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 D ANTIGEN WAS NOT DETECTED WITH ANTI-D SERIES 4 AND ANTI-D SERIES 5 BLOOD GROUPING REAGENTS; A MISSED ANTI-FYA FOR THREE (3) PATIENT SAMPLES DURING AN ANTIBODY SCREEN (TWO EVENTS; ONE INVOLVING TWO PATIENT SAMPLES, AND AT A DIFFERENT CUSTOMER SITE ONE INVOLVING A SINGLE PATIENT SAMPLE); AND A MISSED ANTI-E DURING AN ANTIBODY SCREEN. ON JULY 2, 2023 A CUSTOMER REPORTED AN RH MISTYPE FOR A PATIENT SAMPLE ON THE ECHO LUMENA INSTRUMENT; D ANTIGEN WAS NOT DETECTED WITH ANTI-D SERIES 4 (LOT NUMBER 504056) AND ANTI-D SERIES 5 (LOT NUMBER 505906) ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6). THE CUSTOMER RETESTED WITH MANUAL TUBE METHOD AND RECEIVED THE EXPECTED POSITIVE RESULTS WITH BOTH ANTI-D REAGENTS. NO PATIENT INJURY OR HARM WAS REPORTED. ON JULY 6, 2023 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED ECHO LUMENA INSTRUMENT SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962465 ↗
• MalfunctionJul 31, 2023False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN TWO (2) INSTANCES (INVOLVING 2 PATIENT SAMPLES); TWO (2) ANTIBODY ID ERRORS WERE REPORTED. A REVIEW INDICATED THAT TWO (2) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING FALSE NEGATIVE RESULTS FOR KNOWN OR SUSPECTED ANTIBODIES, INCLUDING: ONE (1) FOR THE ANTI-E ANTIBODY AND ONE (1) ANTI-C ANTIBODY; WHERE THE SAMPLE WAS UNEXPECTEDLY NEGATIVE ON THE ECHO LUMENA INSTRUMENT. A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI-C WHEN TESTED WITH CAPTURE-R READY-ID EXTEND I (LOT NUMBER DP133, EXPIRY JUNE 20, 2023) ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6); CUSTOMER STATES THAT PATIENT HAS A HISTORY OF ANTI-C. NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4). A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI-E WHEN TESTED WITH CAPTURE-R READY-SCREEN 3 (LOT NUMBER R498, EXPIRY SEPTEMBER 27, 2023) WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221311 ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431208 ↗
• MalfunctionJul 26, 2023False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN TWO (2) INSTANCES (INVOLVING 2 PATIENT SAMPLES); TWO (2) ANTIBODY ID ERRORS WERE REPORTED. A REVIEW INDICATED THAT TWO (2) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING FALSE NEGATIVE RESULTS FOR KNOWN OR SUSPECTED ANTIBODIES, INCLUDING: ONE (1) FOR THE ANTI-E ANTIBODY AND ONE (1) ANTI-C ANTIBODY; WHERE THE SAMPLE WAS UNEXPECTEDLY NEGATIVE ON THE ECHO LUMENA INSTRUMENT. A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI-C WHEN TESTED WITH CAPTURE-R READY-ID EXTEND I (LOT NUMBER DP133, EXPIRY JUNE 20, 2023) ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(6); CUSTOMER STATES THAT PATIENT HAS A HISTORY OF ANTI-C. NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4). A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI-E WHEN TESTED WITH CAPTURE-R READY-SCREEN 3 (LOT NUMBER R498, EXPIRY SEPTEMBER 27, 2023) WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221311 ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401977 ↗
• MalfunctionApr 27, 2023False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN FIVE (5) INSTANCES (INVOLVING 6 PATIENT SAMPLES); FIVE (5) ANTIBODY SCREEN ASSAY ERRORS AND FOUR (4) ANTIBODY ID ERRORS WERE REPORTED. A REVIEW INDICATED THAT SIX (6) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM WHEREBY, THE INSTRUMENT PRODUCED FALSE NEGATIVE RESULTS FOR KNOWN OR SUSPECTED ANTIBODIES, INCLUDING: TWO (2) FOR THE ANTI-E ANTIBODY; ONE (1) FOR THE ANTI-FYB ANTIBODY; ONE (1) FOR THE ANTI-FYB ANTIBODY AND ONE (1) FOR THE ANTI-K (KELL) ANTIBODY; WHERE THE SAMPLE WAS UNEXPECTEDLY NEGATIVE ON THE ECHO LUMENA INSTRUMENT. A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI-FYB WHEN TESTED WITH CAPTURE-R READY-ID (LOT NUMBER ID441, EXPIRY FEBRUARY 14, 2023) ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(4); ANTI-FYB WAS IDENTIFIED IN TUBE WITH PEG METHOD AT AHG PHASE AND STRENGTH OF REACTION WAS 3+. NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. CUSTOMER CALLED FOR DOCUMENTATION PURPOSES ONLY AND DID NOT WISH TO FURTHER TROUBLESHOOT AND REFUSED TO PROVIDE MORE INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828521 ↗
• MalfunctionJan 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES, AN ANTIBODY SCREEN ASSAY ERROR; A CROSSMATCH VALIDATION ERROR AND ABO RH MISTYPES. A REVIEW INDICATED THAT THREE (3) PATIENT SAMPLE TESTS [FROM TWO (2) PATIENTS] USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM WHEREBY, THE INSTRUMENT PRODUCED DISCREPANT RESULTS AGAINST KNOWN RESULTS FOR ABORH TYPING. THE THREE (3) INACCURATE RESULTS WERE FOR ANTI-D USING ANTI-D MONOCLONAL SERIES 4 AND 5. A REVIEW INDICATED THAT FIVE (5) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM WHEREBY, THE INSTRUMENT PRODUCED FALSE NEGATIVE RESULTS FOR KNOWN ANTIBODIES, INCLUDING: TWO (2) FOR THE ANTI-E ANTIBODY; ONE (1) FOR THE ANTI-FYB ANTIBODY; ONE (1) FOR THE ANTI-JKA ANTIBODY AND ONE (1) FOR THE ANTI-KPA ANTIBODY; WHERE THE SAMPLE WAS NEGATIVE ON THE ECHO LUMENA AND POSITIVE ON THE NEO IRIS. A REVIEW INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED AN INCOMPATIBLE CROSSMATCH FOR ANTI-C. A REVIEW INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE ECHO LUMENA AUTOMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275237 ↗
• MalfunctionOct 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR ANTIBODIES. A REVIEW INDICATED THAT SIXTEEN (16) PATIENT SAMPLE TESTS (OVER THIRTEEN EVENTS) USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED NINE (9) INACCURATE RESULTS FOR ABO AND RH TESTING. OF THE NINE (9) INACCURATE RESULTS; SEVEN (7) WERE RELATED TO ANTI-D AND TWO (2) WERE RELATED TO ANTI-B IN ADDITION, THE INSTRUMENT HAD UNEXPECTED FALSE NEGATIVE RESULTS FOR ANTIBODIES; INCLUDING: FOUR (4) FOR THE ANTI-E ANTIBODY; TWO (2) FOR THE ANTI-FYA ANTIBODY AND ONE (1) FOR THE ANTI-K ANTIBODY. IN EACH CIRCUMSTANCE, SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ADDITIONAL INVESTIGATIONS RELATED TO QUALITY CONTROL PROCESSES; TEST PROCEDURES AND OTHER FACTS COULD NOT DETERMINE ANY DIRECT CAUSE OF THE MISSED ANTIBODY SCREENING AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705129 ↗
• MalfunctionJul 29, 2022False Negative Result; False Negative Result

  A REVIEW OF EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR ANTIBODIES. A REVIEW INDICATED THAT SEVEN (7) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED EIGHT (8) UNEXPECTED FALSE NEGATIVE RESULTS; THREE (3) FOR THE ANTI-E ANTIBODY; ONE (1) FOR THE ANTI-JKB ANTIBODY; ONE (1) FOR THE ANTI-FYA ANTIBODY AND THREE (3) FOR THE ANTI-S ANTIBODY. IN EACH CIRCUMSTANCE, SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ADDITIONAL INVESTIGATIONS RELATED TO QUALITY CONTROL PROCESSES; TEST PROCEDURES AND OTHER FACTS COULD NOT DETERMINE ANY DIRECT CAUSE OF THE MISSED ANTIBODY SCREENING AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT. ONE (1) INSTRUMENT (B)(4) MALFUNCTION GENERATED INACCURATE ABO TYPING RESULT. THE PATIENT SAMPLE PRODUCED AN ABO RESULT AS O POSITIVE. 24 HOURS LATER THE PATIENT WAS RETYPED IN TUBE WITH THE SAME BLOOD DRAW AND THE TUBE METHOD RESULTED IN A POSITIVE. SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ONE CROSSMATCH EVENT - A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130271 ↗
• MalfunctionMay 2, 2022False Negative Result; False Negative Result

  A REVIEW OF EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT SEVEN PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED NINE UNEXPECTED FALSE NEGATIVE RESULTS; TWO FOR THE ANTI-E ANTIBODY; TWO FOR THE ANTI-JKA ANTIBODY; ONE FOR THE ANTI-FYA ANTIBODY; ONE FOR THE ANTI-K ANTIBODY; ONE FOR THE ANTI-K ANTIBODY, ONE FOR THE ANTI-M ANTIBODY AND ONE FOR THE ANTI-KPA ANTIBODY. IN EACH CIRCUMSTANCE, SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ADDITIONAL INVESTIGATIONS RELATED TO QUALITY CONTROL PROCESSES; TEST PROCEDURES AND OTHER FACTS COULD NOT DETERMINE ANY DIRECT CAUSE OF THE MISSED ANTIBODY SCREENING AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT. TWO ADDITIONAL INSTRUMENT MALFUNCTIONS GENERATED INACCURATE RH TYPING RESULTS BASED ON HISTORICAL RESULTS; WHICH HAD TYPED O POSITIVE. OUR INVESTIGATION REVEALED THAT THE TWO PATIENTS HAD VERY RECENT TRANSFUSIONS OF NEGATIVE BLOOD. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS FOR ANTI-D SERIES 4 AND 5 PRODUCED EXPECTED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257576 ↗
• MalfunctionJan 31, 2022False Negative Result; False Negative Result

  A REVIEW OF EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT TEN (10) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED FIVE (5) UNEXPECTED FALSE NEGATIVE RESULTS FOR THE ANTI-E ANTIBODY; THREE (3) FOR THE ANTI-JKA ANTIBODY; ONE (1) FOR THE ANTI-FYA ANTIBODY; ONE (1) FOR THE ANTI-K ANTIBODY. ONE ADDITIONAL (1) INSTRUMENT MALFUNCTION GENERATED AN INACCURATE ABO RESULT USING THE ABO FORWARD TYPING ASSAY. BASED ON A HISTORICAL RESULT; TYPING FOR ANTI-D WAS INACCURATE. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. NO SINGLE REASON FOR THE FALSE NEGATIVES WAS DETERMINED AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 13397960 ↗
• MalfunctionOct 29, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT TEN (10) PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT EIGHT (8) PATIENT SAMPLE TESTS PRODUCED TWO (2) UNEXPECTED FALSE NEGATIVE RESULTS FOR THE ANTI-E ANTIBODY; ONE (1) FOR THE ANTI-K ANTIBODY; TWO (2) FOR THE ANTI-FYA ANTIBODY; ONE (1) FOR THE ANTI-K ANTIBODY AND TWO (2) FOR THE ANTI-CW ANTIBODY. TWO (2) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABORH RESULTS BASED ON HISTORICAL RESULTS FOR THE PATIENTS USING THE ABO FORWARD TYPING ASSAY; PRODUCING ONE (1) INACCURATE RESULT FOR ANTI-B AND ONE INACCURATE RESULT FOR (1) FOR ANTI-D. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 12721201 ↗
• MalfunctionJul 30, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT THIRTEEN (13) PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED FOUR (4) UNEXPECTED FALSE NEGATIVE RESULTS FOR THE ANTI-FYA ANTIBODY; THREE (3) FOR THE ANTI-E ANTIBODY; TWO (2) FOR THE ANTI-K ANTIBODY; ONE (1) FOR THE ANTI-LUB ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY AND ONE (1) FOR THE ANTI-E ANTIBODY. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 12254079 ↗
• MalfunctionJun 22, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 A CUSTOMER REPORTED THAT AN ONCOLOGY PATIENT TESTED NEGATIVE WITH CAPTURE-R READY-SCREEN 3 ON THE ECHO LUMENA INSTRUMENT ON (B)(6) 2021. PATIENT HAD BEEN TREATED WITH DARATUMUMAB (WHICH MASKED THE ANTIGENS AND CREATED A FALSE NEGATIVE RESULT). ON (B)(6) 2021 THE PATIENT STARTED TO EXPERIENCE A TRANSFUSION REACTION AND WENT TO ANOTHER HOSPITAL FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041414 ↗
• MalfunctionApr 30, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT FOURTEEN (14) PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT TEN (10) PATIENT SAMPLE TESTS USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED THREE (3) UNEXPECTED FALSE NEGATIVE RESULTS FOR THE ANTI-E ANTIBODY; TWO (2) FOR THE ANTI-C ANTIBODY; TWO (2) FOR THE ANTI-JKA ANTIBODY; ONE (1) FOR THE ANTI-FYA ANTIBODY; TWO (2) FOR THE ANTI-K ANTIBODY; ONE (1) FOR THE ANTI-K ANTIBODY AND ONE (1) FOR THE ANTI-CW ANTIBODY. FOUR (4) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO USING THE ABO FORWARD TYPING ASSAY BASED ON HISTORICAL RESULTS FOR THE PATIENTS; WHILE PRODUCING ONE (1) INACCURATE RESULT FOR ANTI-A AND THREE (3) FOR ANTI-D. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 11755601 ↗