AlinIQ 03R89-62Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380740200169), received between Dec 8, 2022 and Dec 12, 2025 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Computer Software 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER REPORTED THE INTERPRETATION FOR THE HBSAG ASSAY WAS INCORRECTLY TRANSFERRED FROM THE AMS SW3.01. THE INITIAL RESULT WAS POSITIVE, BUT THE TWO REPEAT TESTS WERE NEGATIVE AT 052 / 052 S/CO BUT STILL TRANSFERRED THE POSITIVE INTERPRETATION FROM THE AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787370 ↗
• MalfunctionOct 31, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED THAT THE ALINIQ AMS TRANSMITTED A DIFFERENT PATIENT NAME TO THE ANALYZER COMPARED TO THE BARCODE ON THE SAMPLE. THE CUSTOMER CONFIRMED THAT THE PATIENT'S NAME IN THE LIS MATCHED THE PATIENT'S NAME ON THE BARCODE. THIS OCCURRED WHILE TWO SAMPLES (SIDS (B)(6), WERE RUN AT THE SAME TIME. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437511 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS CONSIDERED A USE ERROR. THE CUSTOMER STATED THAT A 52-YEAR-OLD FEMALE PATIENT RECEIVED AN UNNECESSARY BLOOD TRANSFUSION AFTER THE LAB TECHNICIAN MANUALLY VALIDATED A RESULT THAT WAS FLAGGED INVALID AND WAS BLOCKED BY THE ALINIQ AMS CORRECTLY. THE PATIENT RESULTS FOR SID (B)(6) WERE SENT BY THE CUSTOMER¿S HEMATOLOGY PLATFORM (SYSMEX XN1000) TO THE AMS ON (B)(6) 2025 AT 7:51 A.M. THE AMS FUNCTIONED CORRECTLY AND BLOCKED THE RESULT DUE TO AN INVALID DATA FLAG FOR BASOPHILS, EOSINOPHILS, LYMPHOCYTES AND MONOCYTES. THE USE ERROR OCCURRED AS THE LAB TECHNICIAN INCORRECTLY MANUALLY UNBLOCKED THE RESULTS AND MANUALLY VALIDATED THE RESULTS. THE PATIENT RECEIVED A BLOOD TRANSFUSION BASED ON THE RESULTS THAT WERE MANUALLY VALIDATED AND RELEASED BY THE LAB TECHNICIAN (CUSTOMER NOT WILLING TO PROVIDE ANY RESULT DETAILS OR FURTHER INFORMATION). THE CUSTOMER CONFIRMED THAT THE PATIENT IS DOING OKAY AND DID NOT HAVE ANY ADVERSE REACTION TO THE BLOOD TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331161 ↗
• MalfunctionApr 3, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THAT THE NOYTR CALCULATION RULE IS NOT WORKING FOR THE HEMATOLOGY ADVIA PLATFORM. THE NOYTR RULE IS CALCULATED FROM NEUTROPHIL AND IG CELLS. SINCE THE ADVIA PLATFORM DOES NOT MEASURE IG CELLS, THE NOYTR RULE DOES NOT WORK FOR THE ADVIA PLATFORM. HOWEVER, THE NOYTR RULE WORKS WITH THE ALINITY HQ PROCESSING MODULE. THE CUSTOMER INITIAL RUN CBC ON ALINITY HQ PROCESSING MODULE. WHEN THE CUSTOMER HAS A DELTA CHECK OR NEEDS TO REPEAT A COMPLETE BLOOD COUNT (CBC), THEY REPEAT IT ON THE ADVIA PLATFORM. AT THAT TIME, THE CBC+DIFF IS REPORTED FROM ADVIA, AND IG RESULTS COME FROM ALINITY HQ. IN THAT SITUATION, THE TOTAL DIFFERENTIAL COUNT IS HIGHER THAN 100%, WHICH IS INCORRECT. THE DIFFERENTIAL COUNT SHOULD NOT EXCEED 100%. FOR THIS REASON, THE CUSTOMER IS REQUESTING TO REMOVE THE ADVIA HEMATOLOGY PLATFORM FROM THAT RULE FAMILY IN AMS. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ABOUT MISSED OR DELAYED TREATMENTS. THERE WERE NO DISCREPANT PATIENT RESULTS PROVIDED BY THE CUSTOMER. NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766778 ↗
• MalfunctionJan 28, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED THAT AMS ALLOWED THE ORDER ENTRY MODULE TO CREATE A DUPLICATED SID ASSOCIATED TO TWO DIFFERENT REQUESTS. AFTER REVIEW OF LOGS, IT IS VISIBLE THAT SAMPLE (B)(6) WAS FIRSTLY ASSOCIATED TO REQUEST (B)(4), BUT THEN A DUPLICATE WAS ASSIGNED BY ORDER ENTRY TO REQUEST (B)(4) NO TRACE OF UPDATE FROM LIS, ONLY VISIBLE IN ORGANIZER. RESULTS WERE ASSIGNED TO OTHER PATIENT WITH SAMPLE IDENTIFICATION NUMBERS THAT WERE NOT ORDERED FROM HIS. THEY WERE IDENTIFIED AND BLOCKED BEFORE VALIDATION AND REPORTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253123 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS UREA NITROGEN INSTEAD OF URIC ACID RESULTING IN 66 INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. THE CUSTOMERS REVIEW OF POTENTIALLY IMPACTED RESULTS HAS BEEN COMPLETED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED FOR THIS SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633128 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS A UREA NITROGEN INSTEAD OF A URIC ACID RESULTING IN 50 POTENTIALLY INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. PHYSICIANS ARE WORKING TO DETERMINE IF INCORRECT PATIENT RESULTS NEGATIVELY IMPACTED PATIENT MANAGEMENT AT THIS SITE. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT AT THIS SITE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633121 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS A UREA NITROGEN INSTEAD OF A URIC ACID RESULTING IN 66 INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. THE CUSTOMERS REVIEW OF POTENTIALLY IMPACTED RESULTS HAVE BEEN COMPLETED AND CLARIFICATION WAS RECEIVED THAT THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED FOR THIS SITE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633085 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS A UREA NITROGEN INSTEAD OF A URIC ACID RESULTING IN 50 POTENTIALLY INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. PHYSICIANS ARE WORKING TO DETERMINE IF INCORRECT PATIENT RESULTS NEGATIVELY IMPACTED PATIENT MANAGEMENT AT THIS SITE. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT AT THIS SITE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633080 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS A UREA NITROGEN INSTEAD OF A URIC ACID RESULTING IN 50 POTENTIALLY INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. THREE LOCATIONS ((B)(6)) HAVE REVIEWED THEIR SITE¿S RESULTS AND IDENTIFIED 5 IMPACTED PATIENTS. IT WAS REPORTED THAT TWO PATIENTS WERE GIVEN ANTIBIOTIC TREATMENT, TWO PATIENTS WERE NOT DIAGNOSED WITH URIC ACID GOUT, AND ONE WAS TREATED WITH MEDICINE FOR GOUT. THERE WAS NO INFORMATION PROVIDED AS TO WHICH SITE GENERATED THE RESULTS OF THE 5 PATIENTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632949 ↗
• MalfunctionJun 28, 2024Installation-Related Problem; Installation-Related Problem

  THE AMS CONFIGURATION WAS INCORRECTLY SETUP FOR URIC ACID SYNOVIAL FLUID TESTING. THE UPLOAD/DOWN CODES WERE INADVERTENTLY ENTERED FOR THE ANALYZER TO PROCESS A UREA NITROGEN INSTEAD OF A URIC ACID RESULTING IN 50 POTENTIALLY INCORRECT RESULTS WITHIN THIS CUSTOMER'S HEALTH SYSTEM ACROSS MULTIPLE LOCATIONS. THREE LOCATIONS ((B)(6)) HAVE REVIEWED THEIR SITE¿S RESULTS AND IDENTIFIED 5 IMPACTED PATIENTS. IT WAS REPORTED THAT TWO PATIENTS WERE GIVEN ANTIBIOTIC TREATMENT, TWO PATIENTS WERE NOT DIAGNOSED WITH URIC ACID GOUT, AND ONE WAS TREATED WITH MEDICINE FOR GOUT. THERE WAS NO INFORMATION PROVIDED AS TO WHICH SITE GENERATED THE RESULTS OF THE 5 PATIENTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632633 ↗
• MalfunctionFeb 11, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED AN INCORRECT ASSAY WAS PERFORMED WHILE USING THE ALINIQ AMS SOFTWARE. IN THE CUSTOMER¿S LIS (LABORATORY INFORMATION SYSTEM), TEST CODE 162 WAS FOR TOTAL BILIRUBIN IN BODY FLUID (NOT BLOOD). IN THE ALINIQ AMS SOFTWARE, TEST CODE 162 WAS MISCONFIGURED AS DIRECT BILIRUBIN (BODY FLUID). WHEN THE ALINIQ AMS SOFTWARE RECEIVED AN ORDER FOR BODY FLUID (SAMPLES WITH SID ENDING IN .34), IT ORDERED DIRECT BILIRUBIN INSTEAD OF TOTAL BILIRUBIN. THE DIRECT BILIRUBIN RESULTS WERE THEN SENT TO THE CUSTOMER¿S LIS AND WERE BEING REPORTED AS TOTAL BILIRUBIN. THE CUSTOMER PROVIDED THE FOLLOWING AFFECTED PATIENT ID¿S: SID (B)(6). SID (B)(6). SID (B)(6). SID (B)(6). SID (B)(6). SID (B)(6). SID (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682892 ↗
• MalfunctionDec 20, 2023Computer Software Problem; Computer Software Problem

  ON 08DEC2023, THE CUSTOMER PROVIDED A SAMPLE ID (B)(6) THAT WAS SAID TO HAVE INCORRECT DATA POPULATED IN THE ALINIQ AMS BASE SOFTWARE REGARDING A ALINITY I TOTAL B-HCG TEST RESULT. THE FOLLOWING DATA WAS PROVIDED: 1ST RESULT WAS PRIMARY = 964.20 MIU/ML; SECONDARY RESULT TRANSMITTED FROM INSTRUMENT = POSITIVE. 2ND RESULT AFTER RUNNING THE AUTOMATIC DILUTION, PRIMARY RESULT < 7000 MIU/ML; SECONDARY RESULT TRANSMITTED FROM INSTRUMENT = POSITIVE. HOWEVER, AMS READ PRIMARY RESULT < 7000 AND FLAG <, FOR WHICH EXISTS A RULE THAT GENERATES THE RESULT AS ABSENT. IT WAS NOTED THAT THE ALINIQ AMS BASE SOFTWARE WAS INCORRECTLY CONFIGURED FOR THE ALINITY I TOTAL B-HCG RESULT. IT WAS NOTED THAT THE DILUTION WAS AUTOMATICALLY TRIGGERED BY THE AMS DUE TO AN INCORRECT RULE CONFIGURATION. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363824 ↗
• MalfunctionOct 10, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED INCORRECT TESTS LINKED TO A SAMPLE ID NUMBER IN THE ALINIQ AMS BASE SOFTWARE FOR A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT CBC TEST ORDERS (BAR CODE 0014494703), SENT BY THE LIS, WERE MISMATCHED IN THE AMS WITH CLINICAL CHEMISTRY TESTS THAT BELONGED TO ANOTHER SAMPLE (BAR CODE 0014494704). THE RESULTS WERE NOT RELEASED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905031 ↗
• MalfunctionOct 4, 2023Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER OBSERVED TRANSFERRING INCORRECT RESULTS FROM PANEL T25 TO THE NEW CREATED T218 PANEL ON AMS ANIQ SOFTWARE WHICH CONNECTED TO NON-ABBOTT PHADIA1000 ANALYZER. THE CUSTOMER HAS TWO ALLERGY PANEL FOR DIFFERENT ALLERGY TESTING NAMED T25 AND T218 ON NON-ABBOTT PHADIA1000 ANALYZER. THE NEW PRIME T218 PANEL CONFIGURED BY THE ABBOTT FSR. THE ABBOTT FSR CONFIGURED INCORRECT CHANNELS WHICH USED FOR PANEL T25, SO ALL RESULTS FROM T25 PANEL TRANSFERRING TO T218 PANEL. THE CUSTOMER NOTICED INCORRECT RESULTS FOR T218 PANEL COMING TO LIS AND STOPPED SENDING THOSE RESULTS. THERE WERE NO INCORRECT RESULTS REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED WERE: SID (B)(6): 45YRS OLD MALE: T218=< 0.10 /REPEATED=<0.10. SID (B)(6): 65YRS OLD FEMALE: T218=< 0.10 /REPEATED=<0.10. SID (B)(6): 10YRS OLD FEMALE: T218=>100 /REPEATED=0.49 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871725 ↗
• MalfunctionSep 8, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED CEREBROSPINAL FLUID ALBUMIN DILUTION RESULTS DID NOT TRANSFERRED TO LIS BY ALNIQ AMS SOFTWARE WHICH CONNECTED TO ALINITY C PROCESSING MODULE. THE INITIAL CEREBROSPINAL FLUID ALBUMIN RESULT >500 GENERATED, AND AUTO DILUTION PERFORMED CORRECTLY BY THE ALINITY C PROCESSING MODULE. THE CUSTOMER DETERMINED THE ISSUE WHEN THE AMS SOFTWARE TRANSMITTED >500 INITIAL PATIENT RESULT TO LIS FOR CEREBROSPINAL FLUID ALBUMIN AND DID NOT HOLD FOR RERUN AND REPORTED >500 FROM LIS. DURING THE SITE VISIT THE ABBOTT FSR DID NOT SETUP THE REQUESTED RULE BY THE CUSTOMER. THE CUSTOMER REQUESTED TO SETUP RULE TO HOLD >500 CEREBROSPINAL FLUID ALBUMIN RESULTS FOR DILUTION AFTER INSTALLATION, HOWEVER, THE CUSTOMER WROTE THE INCORRECT INFORMATION TO HOLD WHEN CEREBROSPINAL FLUID ALBUMIN RESULTS < 500 INSTEAD OF > 500. AFTER THE INCIDENT, THE CUSTOMER UPDATED FOR REPEAT TESTING RULE SCENARIOS FOR CEREBROSPINAL FLUID ALBUMIN TO BE BLOCKED AND DILUTED IF RESULT IS > 500.00. THE ABBOTT FSR CONFIGURATED THE RULE AS PER CUSTOMER REQUESTED AND VALIDATED BY THE CUSTOMER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711043 ↗
• MalfunctionAug 18, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED THAT ENTEROVIRUS (ENTP) RESULTS RELEASED FROM THEIR ELITE ANALYZER ARE SHOWN UNDER ADENOVIRUS (ADEP) IN THE ALINIQ AMS (ANALYZER MANAGEMENT SYSTEM). THE CUSTOMER STATED THAT RESULTS FOR 92 SAMPLES HAVE BEEN RELEASE SINCE GOING LIVE ON (B)(6), 2023. OF THIS, 14 RESULTS WERE POSITIVE FOR MV OR MV2. OF THIS, 3 WERE IDENTIFIED AS POSITIVE FOR MV2. OF THIS, 2 HAD RESULTS THAT WERE AUTHORIZED AND RELEASED. THE RESULTS WERE QUESTIONED AND THE CLINICAL TEAMS HAVE BEEN CONTACTED AND PATIENTS DISCUSSED. REVIEW OF THE RESULT LOGS IDENTIFIED THAT THE ANALYZER RESULT STRING ORDER NEEDED TO BE UPDATED. THE CORRECTION WAS MADE AND RESULTS ARE NOW BEING ACQUIRED IN THE CORRECT ORDER AND MATCHING EXPECTATIONS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577151 ↗
• MalfunctionJul 25, 2023Problem with Software Installation; Problem with Software Installation

  THE CUSTOMER REPORTED A WRONG CONFIGURATION OF CHANNEL NUMBERS WITH THEIR ALINIQ AMS SOFTWARE. THE CUSTOMER SWITCHED TO NEWER VERSIONS OF TRIGLYCERIDES, IRON, AND ALKALINE PHOSPHATASE ASSAYS WHICH REQUIRED THE CHANNEL NUMBERS FOR THOSE ASSAYS TO CHANGE. THE NEW CHANNEL NUMBER PROVIDED FOR TRIGLYCERIDES WAS ACTUALLY THE CHANNEL NUMBER FOR DIGITOXINE, SO THE SAMPLES THAT WERE TO BE TESTED WITH THE TRIGLYCERIDE WERE ACTUALLY TESTED WITH THE DIGITOXINE ASSAY. THERE WERE 8 PATIENT SAMPLES AFFECTED WITH SAMPLE IDS RANGING FROM (B)(6) AND ALL RESULTS GENERATED WERE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393355 ↗
• MalfunctionJun 7, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED INCORRECT INTERPRETATION OF RESULTS WHEN USING THE ALINIQ AMS BASE SOFTWARE. THE CUSTOMER STATED THAT ON (B)(6) 2023 A SAMPLE ID (B)(6) WAS TESTED AND GENERATED A NUMERIC RESULT OF 1.30 S/CO BUT WITH NO INTERPRETATION POPULATING FROM THE ALINIQ AMS BASE SOFTWARE. HOWEVER, A NEGATIVE INTERPRETATION WAS SENT FROM THE AMS TO THE CUSTOMER¿S LIS WHEN THE INTERPRETATION SHOULD HAVE BEEN POSITIVE. THE PREVIOUS HIV RESULTS FOR THIS SAMPLE HAVE BEEN CORRECTLY TRANSMITTED. ONE SAMPLE RAN ON (B)(6) 2023 WITH A RESULT OF 0.98 S/CO AND SENT A NEGATIVE INTERPRETATION. THE OTHER SAMPLE RAN ON (B)(6) 2023 WITH A RESULT OF 1.28 S/CO AND SENT A POSITIVE INTERPRETATION. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084319 ↗
• MalfunctionApr 10, 2023Problem with Software Installation; Patient Data Problem; Problem with Software Installation; Patient Data Problem

  THE CUSTOMER OBSERVED THE GGT ASSAY WAS CONFIGURED INCORRECTLY IN THE ALINIQ AMS WHICH THEN GENERATED DISCREPANT RESULTS. THE CUSTOMER WAS SWITCHING OVER TO SIGMA STRONG REAGENTS AND AN ABBOTT REPRESENTATIVE RECONFIGURED THE ALINIQ AMS TO THE NEW UPDATED ASSAY CODES FOR GGT, GOT, FAL, FE, LDH, CHOL, AND TRIG. AFTER THE RECONFIGURATION WAS COMPLETED, THE CUSTOMER OBSERVED UNEXPECTED GGT RESULTS THAT WERE HELD IN THE LIS. NO DISCREPANT RESULTS WERE RELEASED FROM THE LABORATORY. THE ALINIQ AMS WAS THEN RECONFIGURED TO THE CORRECT GGT ASSAY CODE. NO SPECIFIC DATA OR SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710715 ↗
• MalfunctionMar 7, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED AN INSTRUMENT ERROR CODE INSTEAD OF A NUMERICAL VALUE WHILE RUNNING THE URINARY BENZODIAZEPINE ASSAY AND THE ERROR CODE WAS INTERPRETED BY ALINIQ AMS AS A ¿NEGATIVE¿ RESULT. THIS OCCURRED AFTER UPGRADING TO VERSION 3.01 OF AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496238 ↗
• MalfunctionFeb 27, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THAT HIV RESULTS AUTO RELEASED FROM ANIQ AMS SOFTWARE THAT CONNECTED TO ALINITY M PROCESSING MODULE. THE CUSTOMER HAS RANGE SETUP IN AMS SOFTWARE THAT HOLD ALL HIV RESULTS IF >50 FOR MANUAL VERIFICATION. THAT RANGE WAS SETUP IN AMS SOFTWARE AT THE TIME OF INSTALLATION AND THAT VALIDATED BY THE CUSTOMER. ON 05FEB2023 ALL HIV RESULTS STARTED AUTO RELEASED WITHOUT HOLDING IF RESULTS >50. THE ABBOTT FSR FOUND THAT SAMPLES ARE PARTIALLY VALIDATED BECAUSE RESULTS ARE NOT BEING COPIED TO THE LIS HIV DUMMY TEST CODE CAUSING SAMPLES TO REMAIN ON ¿TO VALIDATE¿ LIST AND TEST TYPE WAS CHANGED TO TEXTUAL A DAY BEFORE BY ABBOTT REMOTELY. THE ABBOTT FSR RESTARTED THE SERVICES, AND THE RESULTS WERE COPIED TO THE DUMMY TEST AS SAMPLES WERE CLOSING PROPERLY. THERE IS NO INFORMATION REGARDING ANY DISCREPANT RESULTS REPORTED. NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16448486 ↗
• MalfunctionJan 12, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED AN EQA SAMPLE WITH AN ETHANOL RESULT OF <0 MG/L. A RULE WITHIN THE ALINIIQ AMS SOFTWARE WAS USED TO GENERATE THIS RESULT; HOWEVER, THIS IS NOT AN EXPECTED RESULT. THE RESULT BELOW THE LIMIT OF QUANTIFICATION SHOULD BE REPORTED AS <100 MG/L. THE ETHANOL RESULTS WAS INCORRECTLY MULTIPLIED (X10) WHEN RESULTS RECEIVED FROM THE INSTRUMENT WAS <10. WHEN RESULTS WERE RECEIVED FROM INSTRUMENT IT WAS CALCULATED AND SENT TO LIS AS <0. THE CUSTOMER ADDED AN UPDATED STANDARD RULE AND TESTED MANUALLY, AND IT ALL WORKED FINE. 3 SAMPLES WERE TESTED AND RESULTED IN <100 MG/L, 1380 MG/L AND 2710 MG/L. THE LAST TWO WERE IQC SAMPLES AND THE RESULTS WERE APPROXIMATELY 10X THE TARGET VALUES (MEASURED IN MG/DL, SO THIS IS CORRECT). THE FIRST SAMPLE WAS WATER. THE NEW RULE APPEARS TO BE WORKING CORRECTLY. THERE IS NO REPORT OF IMPACT TO PATIENT MANAGEMENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16145727 ↗
• MalfunctionDec 8, 2022Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THE HIL INDEX (HEMOLYSIS, ICTERIC, LIPEMIC INDICES) WERE INCORRECTLY PROGRAMMED INTO THE ALINIQ AMS. AN EXAMPLE PROVIDED WAS THE SODIUM ICTERIC INDEX WAS SET AT 30 INSTEAD OF 60. THE CUSTOMER IS INDICATING THAT MULTIPLE ASSAYS WILL BE IMPACT BY THE HIL INDEX NOT BEING PROGRAMMED CORRECTLY AND POTENTIALLY RESULTS WERE RELEASED THAT SHOULDN¿T HAVE BEEN RELEASED. SAMPLES THAT WERE HEMOLYZED, ICTERIC, OR LIPEMIC MAY HAVE CAUSED ERRONEOUS RESULTS OF AROUND. NO SPECIFIC PATIENT INFORMATION OR DATA OR COMPARISON DATA WAS PROVIDED BUT THERE MIGHT BE AROUND 1000 SAMPLES THAT ARE IMPACTED. THE CUSTOMER INDICATED THAT THE MOST IMPACTED ASSAY WAS FOLATE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939645 ↗