Automated Hematology Analyzer XN series XN-10 AP795756Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04987562424214), received between Oct 13, 2017 and Feb 18, 2026 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Low Test Results

  THE PATIENT RECEIVED TWO UNNECESSARY PACKED RED BLOOD CELL TRANSFUSIONS BASED ON A LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE ANALYZER. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT DUE TO THE UNNECESSARY TRANSFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381746 ↗
• InjuryJul 2, 2025Low Test Results; Low Test Results

  A USER IN BRAZIL REPORTED THAT AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT WAS RELEASED. BASED ON THIS RESULT A PATIENT WAS TRANSFUSED A UNIT OF PACKED RED BLOOD CELLS (PRBC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387506 ↗
• InjuryAug 18, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED ONE PATIENT RECEIVED AN UNNECESSARY RED BLOOD CELL TRANSFUSION BASED ON AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE ANALYZER. NO NEGATIVE PATIENT IMPACT FROM THE TRANSFUSION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577727 ↗
• InjuryMar 22, 2023Low Readings; Low Readings

  THE SAMPLE WAS ANALYZED AND A FALSE LOW PLATELET (PLT) RESULT WAS REPORTED. THE SAMPLE WAS JUDGED NEGATIVE, AND NO SMEAR REVIEW WAS PERFORMED. IT WAS ALLEGED THE PATIENT RECEIVED ONE UNNECESSARY DOSE OF 40 MG PREDNISONE TREATMENT BASED ON THE ERRONEOUS PLT RESULT. THE FOLLOWING DAY, A MANUAL SMEAR OF THE SAMPLE REVEALED PRESENCE OF PLT CLUMPS. THE PREDNISONE TREATMENT WAS DISCONTINUED AFTER THE PLT CLUMPS WERE NOTED. NO NEGATIVE PATIENT IMPACT FROM THE TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590241 ↗
• InjuryFeb 14, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE OPERATOR REPORTED A FALSELY DECREASED HEMOGLOBIN (HGB) RESULT TO THE MEDICAL TEAM. THE PATIENT RECEIVED AN UNNECESSARY RED BLOOD CELL TRANSFUSION. NO NEGATIVE PATIENT IMPACT FROM THE TRANSFUSION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373287 ↗
• InjuryJun 20, 2022High Readings; High Readings

  THE PATIENT IN (B)(6) PRESENTED TO THE HOSPITAL AND A SAMPLE WAS COLLECTED FOR ANALYSIS. THE SAMPLE GENERATED A FALSE HIGH PLATELET (PLT) RESULT. THE PATIENT WAS SENT HOME. THE PATIENT RETURNED TO THE HOSPITAL WITH A NOSEBLEED APPROXIMATELY ONE HOUR LATER AND ANOTHER SAMPLE WAS COLLECTED. THE RECOLLECTED SAMPLE GENERATED A CRITICAL LOW PLT VALUE. PER THE USER, THE PATIENT EXPERIENCED A DELAY OF NECESSARY PLT TRANSFUSION DUE TO THE ERRONEOUS HIGH PLT RESULT REPORTED. NO SERIOUS INJURY OR HARM TO THE PATIENT DUE TO THE DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14748454 ↗
• InjuryJun 15, 2022Use of Device Problem; Use of Device Problem

  THE SAMPLE WAS ANALYZED GENERATING A FALSELY DECREASED PLATELET (PLT) RESULT. THE RESULT WAS RELEASED TO THE MEDICAL TEAM. BASED ON THE FALSELY DECREASED PLT RESULT, THE PATIENT RECEIVED AN UNNECESSARY HEAD COMPUTED TOMOGRAPHY (CT) SCAN. NO PATIENT HARM WAS REPORTED DUE TO THE HEAD CT. THIS EVENT IS BEING REPORTED BECAUSE OF THE UNNECESSARY DIAGNOSTIC EXPOSURE FROM THE HEAD CT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14708108 ↗
• InjuryAug 19, 2021Use of Device Problem; Use of Device Problem

  THE SAMPLE WAS ANALYZED TWICE AND GENERATED SHORT SAMPLE ERRORS. UPON THE THIRD ANALYSIS, A CRITICALLY LOW HEMOGLOBIN (HGB) RESULT OF 3.3 G/DL WAS GENERATED. THE OPERATOR STATED SAMPLE VOLUME WAS SUFFICIENT WITH APPROXIMATELY 1.5ML. A TRANSFUSION OF ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS ADMINISTERED BASED ON THE LOW HGB RESULT. NO NEGATIVE PATIENT IMPACT FROM THE TRANSFUSION WAS REPORTED. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AFTER TRANSFUSION WHICH GENERATED A HGB RESULT OF 10.3 G/DL. THE RESULT WAS INCONSISTENT WITH EXPECTED RESULTS POST-TRANSFUSION (1-2 G/DL INCREASE IN HGB PER UNIT OF PRBC). ANOTHER SAMPLE WAS COLLECTED THE FOLLOWING DAY WHICH GENERATED A HGB RESULT OF 9.7 G/DL. THE OPERATOR SUSPECTS THE HGB RESULTS OF THE ORIGINAL SAMPLE WERE ERRONEOUS, WHICH CONTRIBUTED TO AN UNNECESSARY TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343082 ↗
• InjuryMar 26, 2021Leak/Splash; Leak/Splash

  WHILE INVESTIGATING AN ANALYZER LEAK DURING OPERATION, THE USER OBSERVED WASTE TUBING WAS NOT SECURELY INSERTED INTO THE DRAIN CAUSING WASTE TO SPLASH INTO THE USER'S EYES. THE USER'S EYES WERE IMMEDIATELY FLUSHED BY THE LABORATORY'S EYEWASH STATION, AND THE USER SOUGHT MEDICAL ATTENTION FROM AN EXPOSURE NURSE. THE USER WAS PLACED ON THE (B)(6) PROTOCOL, WHICH INCLUDED TESTING AND THE ADMINISTRATION OF THE PROPHYLACTICS ISENTRESS AND TRUVADA. THE USER SUFFERED EYE IRRITATION FROM THE WASTE SPLASH AND/OR THE EYEWASH, AS WELL AS NAUSEA, VERTIGO, AND VOMITING FROM THE PROPHYLACTICS. IT IS UNKNOWN IF THE USER SOUGHT MEDICAL CARE FOR THE EYE IRRITATION.

  Patient problems: Exposure to Body Fluids; Unspecified Eye / Vision Problem

  MAUDE report 11575783 ↗
• InjuryMar 24, 2021Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT WAS ADMINISTERED AN UNNECESSARY PACKED RED BLOOD CELL (PRBC) TRANSFUSION DUE TO AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE ANALYZER. THE TRANSFUSION WAS STOPPED AFTER AN ACCURATE HGB RESULT FROM REPEAT ANALYSIS ON ANOTHER ANALYZER WAS PROVIDED TO THE CLINICIAN. NO ADVERSE EFFECTS FROM THE TRANSFUSION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565574 ↗
• InjuryDec 1, 2020Use of Device Problem; Use of Device Problem

  THE SAMPLE WAS ANALYZED GENERATING A FALSELY DECREASED HEMOGLOBIN (HGB) RESULT. THE RESULT WAS RELEASED TO THE MEDICAL TEAM AND THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF PACKED RED BLOOD CELLS (PRBC). THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED TO THE EMERGENCY ROOM TWO DAYS LATER WITH CHEST PAIN AND A COMPLETE BLOOD COUNT AND DIFFERENTIAL WAS PERFORMED. A POST TRANSFUSION SAMPLE WAS ANALYZED, GENERATING A HGB RESULT INCONSISTENT WITH THE AMOUNT OF PRBCS TRANSFUSED. THE ORIGINAL SAMPLE WAS REANALYZED AND THE HGB RESULT WAS HIGHER THAN ORIGINALLY GENERATED. THERE WAS NO KNOWN NEGATIVE IMPACT FROM THE TRANSFUSION FOR THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10925033 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AN UNNECESSARY EXPLORATORY KNEE ARTHROSCOPY PROCEDURE DUE TO AN ERRONEOUSLY HIGH WHITE BLOOD CELL BODY FLUID (WBC-BF) RESULT. THE PATIENT'S SYNOVIAL FLUID WAS ANALYZED ON A HEMATOLOGY ANALYZER, AND THE ANALYZER GENERATED AN ACCURATE RESULT. THE USER MANUALLY ENTERED THE WBC-BF RESULT IN THE LABORATORY INFORMATION SYSTEM (LIS). WHEN THE USER MANUALLY ENTERED THE RESULT, THE USER UNINTENTIONALLY REPORTED A VALUE THAT WAS APPROXIMATELY 10 TIMES GREATER THAN THE ACTUAL RESULT. THE FALSELY INCREASED WBC-BF RESULT LED TO THE UNNECESSARY PROCEDURE. NO PATIENT HARM WAS INCURRED DUE TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906245 ↗
• InjuryOct 7, 2020Use of Device Problem; Use of Device Problem

  A USER IN (B)(6) REPORTED A PATIENT WAS ADMINISTERED AN UNNECESSARY PACKED RED BLOOD CELL (PRBC) TRANSFUSION. THE SAMPLE TUBE CONTAINED APPROXIMATELY 1 ML OF SAMPLE AND WAS ANALYZED IN THE SAMPLER MODE. THE SAMPLE WAS JUDGED "POSITIVE" WITH AN INTERPRETIVE PROGRAM (IP) MESSAGE ALERTING THE USER TO SAMPLE ABNORMALITY. AN ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULT WAS GENERATED. THE RESULT WAS RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). BASED ON THE ERRONEOUSLY LOW HGB RESULT, TWO UNITS OF PRBCS WERE TRANSFUSED. A POST TRANSFUSION SAMPLE WAS ANALYZED, GENERATING A HGB RESULT INCONSISTENT WITH THE AMOUNT OF PRBCS TRANSFUSED. THE FIRST SAMPLE WAS REANALYZED, AND A HIGHER HGB RESULT WAS OBTAINED. NO PATIENT HARM WAS INCURRED DUE TO THE TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10644426 ↗
• InjuryJun 10, 2020Use of Device Problem; Use of Device Problem

  A NEWBORN WAS ADMINISTERED ANTIBIOTICS DUE TO ERRONEOUSLY HIGH WHITE BLOOD CELL (WBC) RESULTS. THE FIRST SAMPLE WAS ANALYZED FOR A COMPLETE BLOOD COUNT (CBC) AND AN ERRONEOUSLY HIGH WBC RESULT WAS GENERATED. THE SAMPLE WAS JUDGED "POSITIVE" INDICATING THE NEED FOR FURTHER REVIEW OF THE SAMPLE PRIOR TO RESULT REPORTING. THE USER REPORTED THE CBC RESULTS. A SECOND SAMPLE WAS ANALYZED FOR A CBC AND AN ERRONEOUSLY HIGH WBC RESULT WAS GENERATED. THE SAMPLE WAS JUDGED "POSITIVE." THE USER REPORTED THE CBC RESULTS. A MANUAL SMEAR REVIEW WAS PERFORMED AFTER THE WBC RESULTS WERE REPORTED AND MANY NUCLEATED RED BLOOD CELLS (NRBCS) WERE OBSERVED. THE USER CORRECTED THE WBC AND NRBC RESULTS FOR BOTH SAMPLES. BOTH SAMPLES WERE REANALYZED FOR INVESTIGATIVE PURPOSES AND GENERATED LOWER WBC RESULTS. THE USER REPORTED THE PATIENT WAS TREATED FOR SEPSIS SOON AFTER THE WBC RESULTS WERE REPORTED. THE PROVIDER WAS ATTEMPTING TO RULE OUT SEPSIS DUE TO MULTIPLE FACTORS, ONE FACTOR BEING THE WBC COUNT. THE PATIENT WAS TREATED WITH AMPICILLIN AND GENTAMYCIN. THE TIME OF ANTIBIOTIC ADMINISTRATION WAS NOT PROVIDED. NO HARM TO THE PATIENT WAS REPORTED DUE TO THE ADMINISTRATION OF THE ANTIBIOTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140133 ↗
• InjuryMay 28, 2020Use of Device Problem; Use of Device Problem

  A USER IN (B)(6) ANALYZED A PATIENT SAMPLE FOR A COMPLETE BLOOD COUNT (CBC) AND A NORMAL HEMOGLOBIN (HGB) RESULT WAS GENERATED. THE SAMPLE WAS REPEATED SIX HOURS LATER AND A CRITICAL LOW HGB WAS GENERATED. THE USER REPORTED A DELAY OF GREATER THAN SIX HOURS OF A NECESSARY RED BLOOD CELL (RBC) TRANSFUSION WAS EXPERIENCED BY THE PATIENT DUE TO THE NORMAL HGB RESULT. NO HARM TO THE PATIENT WAS REPORTED DUE TO THE DELAY OF TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099204 ↗
• InjuryMar 18, 2020Use of Device Problem; Use of Device Problem

  THE USER ALLEGED A TRANSFUSION WAS DELAYED APPROXIMATELY 4 HOURS DUE TO AN ERRONEOUSLY HIGH HEMOGLOBIN (HGB) RESULT. THE SUSPECT PATIENT SAMPLE WAS ANALYZED IN THE MANUAL MODE GENERATING A HIGH HGB RESULT WITH AN INTERPRETIVE PROGRAM (IP) MESSAGE, ALERTING THE USER TO SAMPLE ABNORMALITY. THE SUSPECT HGB RESULT WAS TRANSMITTED TO WORK AREA MANAGER (WAM) MIDDLEWARE. A WAM RULE TRIGGERED BASED ON THE ORDERING CRITERIA AND AUTO VALIDATED THE SUSPECT HGB RESULT TO THE LABORATORY INFORMATION SYSTEM (LIS). THE SUSPECT HGB RESULT WAS HIGHLIGHTED IN WAM, INDICATING THE HGB RESULT FAILED A DELTA CHECK, BECAUSE THE PREVIOUS SAMPLE FOR THIS PATIENT HAD A LOW HGB RESULT. THE USER WAS UNAWARE OF THE DELTA CHECK DUE TO AUTO VALIDATION OF THE SUSPECT SAMPLE. A NEW SAMPLE WAS DRAWN APPROXIMATELY 4 HOURS LATER. THE NEW SAMPLE WAS ANALYZED, GENERATING A CRITICALLY LOW HGB RESULT. WHEN THE USER CALLED THE CRITICALLY LOW HGB RESULT, THE NURSE QUESTIONED THE SUSPECT HGB RESULT. THE USER REANALYZED THE SUSPECT SAMPLE, WHICH GENERATED A CRITICALLY LOW HGB RESULT. THERE WAS NO REPORT OF HARM TO THE PATIENT DUE TO THE TRANSFUSION DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9849958 ↗
• InjuryDec 30, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN OPERATOR IN (B)(6) ANALYZED A PATIENT SAMPLE AND AN ERRONEOUS LOW PLATELET (PLT) RESULT WAS GENERATED. THE RESULT WAS REPORTED TO THE MEDICAL TEAM AND THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF PLTS. THE PATIENT'S BLOOD WAS DRAWN POST TRANSFUSION AND THE SPECIMEN WAS ANALYZED. A LOW PLT RESULT WAS GENERATED, TRIGGERED A DELTA CHECK AND THE RESULT WAS HELD. THE OPERATOR PERFORMED A SMEAR REVIEW AND PLT CLUMPS WERE OBSERVED. DUE TO THE PRESENCE OF PLT CLUMPS ON THE SECOND SAMPLE, THE OPERATOR SUSPECTED THE FIRST SAMPLE PLT RESULT WAS ERRONEOUSLY LOW. THERE WAS NO HARM TO THE PATIENT REPORTED DUE TO THE UNNECESSARY PLT TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9532931 ↗
• InjuryDec 11, 2019Use of Device Problem; Use of Device Problem

  THE SAMPLE, COLLECTED IN EDTA, WAS ANALYZED AND GENERATED A FALSELY DECREASED PLATELET (PLT) VALUE. THE SAMPLE WAS REPEATED WITH THE SAME LOW PLT VALUE AND WAS REPORTED TO THE CLINICIAN WITH A COMMENT THAT THIS RESULT WAS NOT YET VERIFIED BY MANUAL SMEAR REVIEW. A MANUAL SMEAR REVIEW CONFIRMED THE PRESENCE OF PLT CLUMPS. A NEW SAMPLE, COLLECTED IN EDTA, WAS ANALYZED A FEW HOURS LATER AND GENERATED THE SAME LOW PLT VALUE. A MANUAL SMEAR REVIEW CONFIRMED THE PRESENCE OF PLT CLUMPS. NEW SAMPLES IN AN EDTA TUBE AND A SODIUM CITRATE TUBE WERE COLLECTED FROM THE PATIENT. THE EDTA SAMPLE GENERATED A LOW PLT RESULT AND THE SODIUM CITRATE TUBE GENERATED A NORMAL PLT RESULT. MANUAL SMEARS WERE PERFORMED ON BOTH SAMPLES WHICH REVEALED THE PRESENCE OF PLT CLUMPS. THE RESULTS OF THE MANUAL SMEAR REVIEWS, WHICH INCLUDED THE PRESENCE OF PLT CLUMPS, WERE REPORTED TO THE CLINICIAN. THE USER STATED THE CLINICIAN DECIDED TO PERFORM A CESAREAN SECTION USING GENERAL ANESTHESIA INSTEAD OF EPIDURAL AFTER THE INITIAL FALSELY DECREASED PLT RESULT WAS REPORTED, EVEN THOUGH THE PROCEDURE WAS PERFORMED AFTER THE CORRECT RESULTS WERE REPORTED TO THE CLINICIAN. NO HARM TO THE PATIENT OR THE BABY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9450949 ↗
• InjuryOct 11, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 10/28/2019 SYSMEX KOREA PROVIDED ADDITIONAL INFORMATION. AN OPERATOR IN KOREA ANALYZED A PATIENT SAMPLE WHICH GENERATED AN ERRONEOUS LOW PLATELET (PLT) VALUE. THE PLT RESULT WAS REPORTED TO THE MEDICAL TEAM. THE DOCTOR REQUESTED THAT THE OPERATOR CONFIRM THE PLT RESULT. THE SAMPLE WAS REANALYZED. THE PLT RESULT WAS NEAR THE NORMAL REFERENCE RANGE AND A CORRECTED REPORTED WAS ISSUED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT RECEIVED AN UNNECESSARY PLT CONCENTRATE TRANSFUSION. IT WAS LATER CONFIRMED THERE WAS NO PLT TRANSFUSION ADMINISTERED. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9180687 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SAMPLE WAS ANALYZED AND GENERATED A FALSE LOW PLATELET (PLT) RESULT. THE ANALYZER GENERATED A "THROMBOCYTOPENIA" FLAG ALERTING THE USER TO VERIFY RESULTS. A SMEAR WAS REVIEWED AND CLUMPS OF 2-3 PLTS PER EVERY FEW HIGH-POWERED FIELDS WERE NOTED. A PLT ESTIMATE WAS NOT PERFORMED. THE COMPLETE BLOOD CELL COUNT (CBC) RESULTS WERE RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). TWO UNITS OF PLTS WERE ORDERED AND TRANSFUSED. A POST TRANSFUSION SAMPLE WAS ANALYZED AND A NORMAL PLT RESULT WAS GENERATED. A PRE-TRANSFUSION SODIUM CITRATE SAMPLE WAS ANALYZED AND A NORMAL PLT RESULT WAS GENERATED. NO CORRECTED REPORT WAS ISSUED. THE PATIENT RECEIVED TWO UNNECESSARY PLT TRANSFUSIONS DUE TO THE ERRONEOUS LOW PLT RESULT. NO PATIENT HARM INCURRED FROM THE TRANSFUSIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896949 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SAMPLE COLLECTED IN EDTA ANTICOAGULANT WAS ANALYZED AND GENERATED A FALSE LOW PLATELET (PLT) VALUE. THE SAMPLE WAS JUDGED "POSITIVE" WITH MULTIPLE FLAGS, ALERTING THE USER TO ABNORMAL RESULTS. THE SAMPLE WAS REANALYZED ON A SECOND ANALYZER AND WAS JUDGED "POSITIVE" WITH MULTIPLE FLAGS. A PERIPHERAL BLOOD SMEAR WAS REVIEWED AND PLT CLUMPING WAS OBSERVED. A FALSELY LOW PLT RESULT WAS REPORTED BY THE LAB ACCOMPANIED WITH A COMMENT: "ACTUAL PLATELET COUNT MAY BE HIGHER BECAUSE PLATELET CLUMPS WERE SEEN.' A NEW COLLECTION IN SODIUM CITRATE ANTICOAGULANT WAS REQUESTED. THE PHYSICIAN ORDERED 1 UNIT OF PLATELETS FOR TRANSFUSION. A SODIUM CITRATE TUBE WAS COLLECTED AFTER THE ERRONEOUS PLATELET COUNT HAD BEEN RELEASED. THIS SAMPLE GENERATED A NORMAL PLATELET COUNT AND THE ORIGINAL RESULT WAS CORRECTED. THE CORRECTED RESULT WAS CALLED TO THE CLINICIAN AS THE PATIENT WAS BEING TRANSFUSED. NO HARM WAS REPORTED DUE TO THE TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8760034 ↗
• InjuryMay 29, 2019Use of Device Problem; Use of Device Problem

  AN OPERATOR IN (B)(6) ANALYZED THE PATIENT SAMPLE AND A FALSELY LOW HEMOGLOBIN (HGB) RESULT WAS GENERATED. THE SAMPLE WAS JUDGED POSITIVE WITH SEVERAL FLAGS ALERTING THE OPERATOR TO POSSIBLE SAMPLE ABNORMALITY. THE OPERATOR REPORTED THE LOW HGB VALUE TO THE CLINICIAN, WITHOUT FURTHER VERIFICATION OF ACCURATE RESULTS. THE SAMPLE WAS SENT TO ANOTHER LAB FOR CROSSMATCH AND REPEAT TESTING. REANALYSIS GENERATED A HIGHER HGB VALUE, THE CLINICIAN WAS NOT NOTIFIED OF THE CHANGE IN HGB VALUE AND NO CORRECTED REPORTS WERE ISSUED. THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF PACKED RED BLOOD CELLS (RBCS). THE CLINICIAN WAS NOTIFIED OF THE HIGHER HGB RESULT AFTER THE PATIENT HAD BEEN TRANSFUSED. THIS EVENT IS REPORTABLE TO THE FDA AS AN UNNECESSARY RBC TRANSFUSION WAS ADMINISTERED TO THE PATIENT DUE TO A FALSELY DECREASED HGB RESULT. NO PATIENT HARM WAS REPORTED BASED ON THE TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8649983 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SAMPLE WAS ANALYZED GENERATING A DECREASED IMPEDANCE PLATELET (PLT-I) COUNT OF 43 X 10^3/UL. THE SAMPLE WAS REANALYZED THE SAME DAY FOR A FLUORESCENCE PLT ( PLT-F) AND GENERATED A PLT-F ZERO VALUE. THE USER REPORTED A PLT RESULT OF LESS THAN 4 X 10^3/UL TO THE LABORATORY INFORMATION SYSTEM (LIS). A PERIPHERAL SMEAR WAS PREPARED AND THE PLT ESTIMATE WAS REPORTED AS "DECREASED". THE PATIENT WAS TRANSFUSED ONE UNIT OF PLATELETS BASED ON THE REPORTED RESULTS. A NEW BLOOD SAMPLE WAS COLLECTED AND ANALYZED POST TRANSFUSION, GENERATING A PLT COUNT OF 72 X 10^3/UL. REPEAT ANALYSIS FOR PLT-F GENERATED A ZERO VALUE. A SLIDE WAS PREPARED AND THE PLT ESTIMATE DID NOT AGREE WITH THE PLT-F RESULT. THE SAMPLE WAS REPEATED TWO MORE TIMES FOR PLT ANALYSIS, GENERATING PLT RESULTS OF 69 X 10^3/UL AND 71 X 10^3/UL. THE USER REPORTED A PLT RESULT OF 69 X 10^3/UL AND A PLT ESTIMATE OF "DECREASED" TO THE LIS. A CORRECTED REPORT WAS ISSUED FOR THE INITIAL SAMPLE TO CHANGE THE PLT RESULT FROM A VALUE OF < 4 X 10^3/UL TO A PLT VALUE OF 43 X 10^3/UL. THERE WAS NO KNOWN NEGATIVE IMPACT FROM THE TRANSFUSION FOR THE INVOLVED PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283610 ↗
• MalfunctionJul 27, 2018Fire; Melted; Smoking; Fire; Melted; Smoking

  A USER IN (B)(6) REPORTED A BURNING ODOR AND FLAMES COMING FROM INSIDE THE ANALYZER. THE USER UNPLUGGED THE POWER CABLE AND USED A FIRE EXTINGUISHER. A FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE AND DISCOVERED LEAKAGE FROM VALVE ASSEMBLY 22. INITIAL ASSESSMENT INDICATES THAT THE FIRE OCCURRED ON VALVE ASSEMBLY 19, WHICH IS BELOW VALVE ASSEMBLY 22. DIAPHRAGMS, WIRING CORDS, AND PROTECTIVE PLASTIC SHEETS WERE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726867 ↗
• InjuryMay 30, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A NEWBORN WAS ADMINISTERED GENTAMYCIN DUE TO AN ERRONEOUSLY HIGH WHITE BLOOD CELL (WBC) RESULT. THE SAMPLE WAS ANALYZED FOR A COMPLETE BLOOD COUNT AND DIFFERENTIAL. THE SAMPLE WAS JUDGED "POSITIVE" INDICATING THE NEED FOR FURTHER REVIEW OF THE SAMPLE PRIOR TO RESULT REPORTING. REPEAT ANALYSIS WAS PERFORMED, AND THE SAMPLE WAS JUDGED "POSITIVE" WITH AN INCREASED WBC VALUE. A SMEAR REVIEW WAS PERFORMED AND THE PRESENCE OF MANY NUCLEATED RED BLOOD CELLS (NRBCS) WAS OBSERVED. THE USER FAILED TO CORRECT THE WBC VALUE FOR THE PRESENCE OF NRBCS PRIOR TO RELEASING THE WBC VALUE. AN ORDER WAS WRITTEN TO ADMINISTER 2 MG/ML OF GENTAMYCIN ON (B)(6) 2018 AT 06:45. IT IS UNKNOWN WHEN THE ANTIBIOTIC WAS ADMINISTERED. IT IS UNKNOWN IF OTHER CLINICAL SIGNS AND SYMPTOMS WARRANTED THE ANTIBIOTIC TREATMENT. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555161 ↗