Galileo Echo 0087000Recalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 10888234001584), received between Apr 13, 2016 and Apr 30, 2026 — classified as 242 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (209 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 242 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 TWO (2) EVENTS USING THE GALILEO ECHO V2.0 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 25049340 ↗
• MalfunctionJan 30, 2026False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THREE (3) EVENTS USING THE GALILEO ECHO V2.0 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 24219060 ↗
• MalfunctionOct 31, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED TEN (10) EVENTS USING THE GALILEO ECHO V2.0 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 23442465 ↗
• MalfunctionJul 23, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED TWO (2) EVENTS USING THE GALILEO ECHO V2.0 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 22573446 ↗
• 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 21368611 ↗
• MalfunctionJan 31, 2025False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED 5 EVENTS USING THE GALILEO ECHO V2.0 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 21287560 ↗
• MalfunctionNov 5, 2024False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR FOUR (4) 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 FOUR (4) PATIENT/DONOR SAMPLES TESTED USING THE GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-K DURING AN ANTIBODY SCREEN; A MISSED UNSPECIFIED ANTIBODY DURING AN ANTIBODY SCREEN; A MISSED ANTI-E AND ANTI-C DURING AN ANTIBODY SCREEN AND ID. ALL EVENTS OCCURRED DURING INSTRUMENT VALIDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611307 ↗
• MalfunctionOct 31, 2024False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR THREE (3) 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 THREE (3) PATIENT/DONOR SAMPLES TESTED USING THE GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-K DURING AN ANTIBODY SCREEN; AND A MISSED ANTI-E AND ANTI-C DURING AN ANTIBODY SCREEN AND ID. ALL EVENTS OCCURRED DURING INSTRUMENT VALIDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575685 ↗
• MalfunctionApr 29, 2024False Positive Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR ONE (1) PATIENT SAMPLE 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 ONE (1) PATIENT SAMPLE TESTED USING THE GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: UNEXPECTED ABO TYPING RESULT. ON (B)(6) 2024 A CUSTOMER REPORTED THAT THEY RECEIVED AN UNEXPECTED ABO TYPING RESULTS ON THE ECHO V2.0 INSTRUMENT FOR ONE PATIENT SAMPLE. CUSTOMER STATES THAT SAMPLE RESULTED AB POS USING ABODCHECK2 ASSAY ON ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6); BUT PATIENT IS HISTORICALLY KNOWN A POS. CUSTOMER RETESTED THE SAME SAMPLE WITH THE SAME REAGENTS SOME MINUTES AFTER AND RESULTED A POS WITH ANTI A SCORE 4+ AND ANTI B SCORE 0. ON (B)(6) 2024 IMMUCOR TECHNICIANS USED REMOTE ACCESS TO REVIEW THE ORIGINAL RESULTS; IT WAS VERIFIED THAT THE SAMPLE WAS INTERPRETED AS AB POS WITH SCORE ON ANTI A 4+ ON ANTI B 2+ (AGGLUTINATION VALUE 43). ON MARCH 12, 2024 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6) AT THE CUSTOMER SITE. THE FSE PROACTIVELY REPLACED NEEDLE AND CALIBRAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19208941 ↗
• MalfunctionJan 31, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  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 REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619513 ↗
• MalfunctionOct 18, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR TWO (2) 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 TWO (2) PATIENT/DONOR SAMPLES TESTED USING THE GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-C AND ANTI-E FROM SAME SAMPLE DURING AN ANTIBODY SCREEN; AND AN UNEXPECTED WEAK-D POSITIVE FOR A PATIENT WITH NO PREVIOUS HISTORY OF WEAK-D. ON SEPTEMBER 28, 2023 A CUSTOMER REPORTED MISSED ANTI-C AND ANTI-E FROM SAME SAMPLE WITH CAPTURE-R READY-SCREEN 3 LOT NUMBER R517 (EXPIRY OCTOBER 24, 2023) AND CAPTURE-R READY INDICATOR RED CELLS LOT NUMBER 221379 ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6). NO PATIENT INJURY OR HARM WAS REPORTED. IMMUCOR CONFIRMED THE C ANTIGEN ON ALL C POSITIVE CELLS AND THE E ANTIGEN ON ALL E POSITIVE CELLS ON RETURNED CAPTURE-R READY-SCREEN 3 LOT NUMBER R517 BY CAPTURE METHOD USING RETENTION ANTI-C, RETENTION ANTI-E AND RETENTION CAPTURE-R READY INDICATOR RED CELLS LOT NUMBER 221379: CONTROLS PERFORMED AS EXPECTED; ALL C POSITIVE CELLS RESULTED POSITIVE WITH RETENTION ANTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962463 ↗
• MalfunctionSep 21, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023 A CUSTOMER REPORTED THAT A PATIENT HAD A HEMOLYTIC TRANSFUSION REACTION.

  Patient problems: Transfusion Reaction

  MAUDE report 17795777 ↗
• MalfunctionAug 16, 2023Mechanical Problem; Mechanical Problem

  ON (B)(6), 2023 A CUSTOMER REPORTED THAT AN OPERATOR RECEIVED A MINOR INJURY WHEN THE OPENED FLUIDICS COVER ON THEIR GALILEO ECHO V2.0 INSTRUMENT UNEXPECTANLY FELL DOWN DURING THE DECONTAMINATION PROCESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17558805 ↗
• MalfunctionJul 31, 2023False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE GALILEO ECHO V2.0 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 GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING FALSE NEGATIVE RESULTS FOR KNOWN OR SUSPECTED ANTIBODIES, INCLUDING: TWO (2) FOR THE ANTI-K (KELL) ANTIBODY; WHERE THE SAMPLE WAS UNEXPECTEDLY NEGATIVE ON THE GALILEO ECHO V2.0 INSTRUMENT. A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI- K (KELL) WHEN TESTED WITH CAPTURE-R READY-ID (LOT NUMBER ID448, EXPIRY JUNE 6, 2023) WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221264 ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6). ANTI- K (KELL) WAS IDENTIFIED ON THE SAME INSTRUMENT CAPTURE-R READY-ID EXTEND II LOT NUMBER DN141 WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221264. 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 NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431209 ↗
• MalfunctionJul 26, 2023False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE GALILEO ECHO V2.0 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 GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING FALSE NEGATIVE RESULTS FOR KNOWN OR SUSPECTED ANTIBODIES, INCLUDING: TWO (2) FOR THE ANTI-K (KELL) ANTIBODY; WHERE THE SAMPLE WAS UNEXPECTEDLY NEGATIVE ON THE GALILEO ECHO V2.0 INSTRUMENT. A PATIENT SAMPLE WAS UNEXPECTEDLY NEGATIVE FOR ANTI- K (KELL) WHEN TESTED WITH CAPTURE-R READY-ID (LOT NUMBER ID448, EXPIRY JUNE 6, 2023) WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221264 ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6); ANTI- K (KELL) WAS IDENTIFIED ON THE SAME INSTRUMENT CAPTURE-R READY-ID EXTEND II LOT NUMBER DN141 WITH CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221264. 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 NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401979 ↗
• MalfunctionApr 30, 2023False Positive Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT SAMPLES TESTED ON THE GALILEO ECHO V2.0 AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN ONE (1) COMPLAINT INSTANCE (INVOLVING 1 PATIENT SAMPLE). A CUSTOMER REPORTED A RH MISTYPE WITH ANTI-D SERIES 4 AND ANTI-D SERIES 5 ON ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(6). ANTI-D4/D5 BOTH SHOWED 1+ REACTIONS BUT CUSTOMER BELIEVED POSITIVE RH IS DISCREPANT RESULT AND NEG RH IS EXPECTED. INITIAL SAMPLE WAS RESULTING AS B NEG BY TUBE METHOD; WEAK D IN TUBE WAS ALSO NEG. A SECOND DRAW FROM THE SAME PATIENT WAS ALSO TESTED ON THE SAME ECHO INSTRUMENT AND BY TUBE METHOD USING THE SAME REAGENTS AS FIRST USED, WITH BOTH RESULTING RH NEGATIVE AS EXPECTED. IMMUCOR USED REMOTE ACCESS TO REVIEW THE ECHO'S RESULTS FROM BOTH SAMPLES; THE INITIAL SAMPLE WELLS APPEAR VISUALLY AS MIXED FIELD. A SAMPLE RELATED ISSUE CANNOT BE RULED OUT (MIXED FIELD REACTIONS ARE A LABELED LIMITATION). PER ECHO LIMITATION: "THE GALILEO ECHO CANNOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS THAT ARE GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY. THE GALILEO ECHO DOES NOT GENERATE AN INTERPRETATION OF MIXED-FIELD. SUCH A MIXED-FIELD REACTION WILL BE INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841516 ↗
• MalfunctionMar 5, 2021Naturally Worn; Naturally Worn

  ON FEBRUARY 3, 2021 A LABORATORY TECHNICIAN AT A CUSTOMER SITE WAS INJURED BY THE FALLING FLUIDICS COVER OF A GALILEO ECHO ((B)(4)) INSTRUMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 11421602 ↗
• MalfunctionOct 16, 2020Naturally Worn; Naturally Worn

  ON (B)(6) 2020 A LABORATORY TECHNICIAN AT A CUSTOMER SITE WAS INJURED BY THE FALLING FLUIDICS COVER OF A GALILEO ECHO (V2.0) INSTRUMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 10693775 ↗
• MalfunctionJul 30, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE ECHO V2 AUTOMATED BLOOD BANK SYSTEM PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES AND FOR RH TYPING EXPECTATIONS. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ANTIBODY AND THE ANTI-K ANTIBODY ON ONE (1) OCCASION WHEN USING THE CAPTURE R READY ID REAGENT. THE MALFUNCTION DID NOT SHOW PRODUCE RH TYPING RESULTS AS EXPECTED ON TWO (2) OCCASIONS. 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: Test Result

  MAUDE report 10345948 ↗
• MalfunctionApr 30, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE ECHO AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE ECHO AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT FOR THE ANTI-K ANTIBODY. TWO (2) INSTRUMENT MALFUNCTIONS PRODUCED AN RH MISTYPE WITH ONE SAMPLE PRODUCING AN UNEXPECTED POSITIVE FOR ANTI-A AND A SECOND PRODUCING AN UNEXPECTED POSITIVE FOR THE B ANTIGEN DURING FORWARD ONLY ABO TYPING; WHEREBY, THE RESULT SHOULD HAVE BEEN A+ BASED ON HISTORICAL RESULTS. 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: No Known Impact Or Consequence To Patient

  MAUDE report 10016381 ↗
• MalfunctionApr 9, 2020False Negative Result; False Negative Result

  ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE CAPTURE-R READY-ID RESULT ON THE GALILEO ECHO V2.0 INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946871 ↗
• MalfunctionJan 31, 2020Circuit Failure; Circuit Failure

  ON (B)(6) 2020 AN IMMUCOR SERVICE TECHNICIAN WAS PERFORMING A CAMERA MODULE UPGRADE ON A GALILEO ECHO INSTRUMENT WHEN THEY NOTED A SPARK AND SMOKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655778 ↗
• MalfunctionJan 29, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT 3 PATIENT SAMPLES TESTED ON THE ECHO AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT 1 PATIENT SAMPLE TEST USING THE ECHO AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT FOR THE ANTI-K ANTIBODY. 2 INSTRUMENT MALFUNCTIONS PRODUCED AN RH MISTYPE UTILIZING ANTI-D4 AND ANTI-D5 ASSAYS BASED ON HISTORICAL RESULTS FOR THE PATIENTS. 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: Test Result

  MAUDE report 9644960 ↗
• MalfunctionNov 20, 2019Leak/Splash; Leak/Splash

  ON (B)(6) 2019 CUSTOMER REPORTED THAT AN OPERATOR WAS SPLASHED IN THE EYES WITH POTENTIALLY INFECTIOUS MATERIAL WHILE REMOVING WASTE RESERVOIR FROM ECHO INSTRUMENT. NO INJURY REPORTED BUT MEDICAL FOLLOW-UP WAS SOUGHT AFTER EXPOSURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9349199 ↗
• MalfunctionOct 29, 2019False Negative Result; Mechanical Problem; False Negative Result; Mechanical Problem

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE ECHO AUTOMATED BLOOD BANK SYSTEM PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ANTIBODY ON ONE (1) OCCASION WHEN USING THE CAPTURE R READY ID REAGENT. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-C ANTIBODY ON ONE (1) OCCASION WHEN USING THE CAPTURE R READY ID REAGENT. WHEN THE CUSTOMER ADJUSTED THE WELL RESIDUAL VOLUME (WRV) THE SAMPLE RESULTS WERE AS EXPECTED. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON ONE (1) OCCASION WHEN USING THE CAPTURE R READY SCREEN 3 REAGENT. 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 DETERMI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252159 ↗