cobas&#x00AE infinity central lab 07154003001Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04015630936007), received between Aug 6, 2018 and Feb 20, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (22 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 12, 2022Class IIOpen, Classified

   A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

   Z-0952-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Jun 24, 2021Class IITerminated

   Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

   Z-2444-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Application Program Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH COBAS INFINITY CORE SOFTWARE VERSION 3.03.38. THE CUSTOMER ALLEGED A MISSING DELTA CHECK FLAG. AN EXAMPLE OF THE ISSUE WAS PROVIDED FOR 1 PATIENT WITH A PSA TEST. ON (B)(6) 2025, THE PSA RESULT WAS 2.81, AND A DELTA CHECK FLAG WAS TRIGGERED BASED ON THE PREVIOUS RESULT OF 5.12 ON (B)(6) 2024. ON (B)(6) 2026, THE PSA RESULT WAS 4.07, AND A DELTA CHECK FLAG WAS NOT TRIGGERED BASED ON THE PREVIOUS RESULT OF 2.79 ON (B)(6) 2025. NO UNIT OF MEASURE WAS PROVIDED FOR THE PSA TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400884 ↗
• MalfunctionSep 6, 2024Computer Software Problem; Computer Software Problem

  WE RECEIVED AN ALLEGATION THAT COBAS INFINITY TRANSMITTED A WRONG RESULT TO THE LABORATORY INFORMATION SYSTEM (LIS). THE REPORTER STATED THAT COBAS INFINITY WAS TRANSMITTING AN INCORRECT RESULT TO THE LIS INSTEAD OF AN EMPTY RESULT WHEN THE EXTINCTION LIMIT (FLAG 46) WAS REACHED. THE REPORTER WAS NOT ABLE TO PROVIDE ANY EXAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156610 ↗
• MalfunctionDec 19, 2023Application Program Problem; Application Program Problem

  WE RECEIVED AN ALLEGATION OF AN ISSUE WITH COBAS INFINITY CORE SOFTWARE VERSION 3.03.17. THE ERROR CODE "3428" SENT BY THE INSTRUMENT WAS CAPTURED AS A PATIENT RESULT FOR THE GGT2 TEST. THIS "RESULT" WAS MANUALLY VALIDATED BY THE CUSTOMER AND RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356474 ↗
• MalfunctionDec 14, 2023Computer Software Problem; Computer Software Problem

  WE RECEIVED AN ALLEGATION ABOUT A SOFTWARE RULE NOT BEING USED AS EXPECTED WHEN TESTING A PATIENT'S SAMPLE WITH ELECSYS PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY ON A COBAS INFINITY CORE LICENSE. PSA RESULT: 100.0 NG/ML. THE REPORTER ALLEGED THAT THE RULE FOR THE PSA TEST THAT PERFORMS THE ACTION TO HOLD THE VALIDATION AND CHANGE THE RESULT TO AUTO-DILUTION "AUTOD" WAS NOT TRIGGERED. THE LABORATORY STAFF SAW THE RESULT ON THE PATIENT CHART AND ALSO NOTICED THAT IT WAS STILL RUNNING ON THE INSTRUMENTS AND THE INSTRUMENTS GAVE A DILUTION SYMBOL. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED BEFORE ANY ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330164 ↗
• MalfunctionAug 11, 2023Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH A COBAS INFINITY CORE SOFTWARE LICENSE VERSION 3.03.15. THE CUSTOMER STATED THAT HIGH AND LOW ALARMS RELATED TO REFERENCE RANGES ARE NOT BEING SENT WHEN RESULTS ARE MIGRATED INTO A PATIENT'S CHART. WHEN A TEST RESULT HAS THE TEST ALARMS TH (ABOVE REFERENCE RANGE) AND TTH (RESULT WITHIN UPPER TOLERANCE LIMIT), THE INFORMATION SENT IN THE SEND RESULTS MESSAGE TO THE HOST IS NOT SENDING THE ALARMS AS EXPECTED. ADDITIONALLY, IT WAS STATED THAT THE SOFTWARE WAS STILL SENDING AN ALARM INDICATING A RESULT WITHIN THE UPPER TOLERANCE LIMIT EVEN THOUGH THE ALARM WAS REMOVED FROM THE MENU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514805 ↗
• MalfunctionJul 20, 2023Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY CORE LICENSE. THE REPORTER STATED THAT THEY HAVE A TEST RULE CALLED "HIV-FLAG-TITERMIN" THAT, UPON RECEIVING THE RESULT FROM THE "HIV-ALAR" TEST, IT WOULD ENTER A TEXT RESULT IN THE "HIV1" TEST. THE REPORTER STATED FOR A SINGLE SAMPLE FROM THEIR RUN, THE RULE WAS NOT APPLIED EVEN THOUGH IT MET THE RULE'S REQUIREMENTS. ON TROUBLESHOOTING, THEY COPIED THE MESSAGE SENT BY THE EQUIPMENT AND SIMULATED IT, AND THE RULE WAS APPLIED. IN THE SAME RUN, THERE WERE OTHER IDENTICAL RESULTS WHERE THE RULE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363015 ↗
• MalfunctionJun 6, 2023Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. A SAMPLE TEST RESULT SENT BY AN INSTRUMENT TO THE COBAS INFINITY SOFTWARE WITH A DATA FLAG INDICATING THE VALUE WAS OVER THE TECHNICAL LIMIT OF THE ASSAY. THE VALUE WAS EXPECTED TO BE FLAGGED WITH THE STATUS "BLOCKED BY INSTRUMENT ALARM" (BIA), BUT THE COBAS INFINITY SOFTWARE DID NOT ADD THIS FLAG TO THE RESULT. THE ISSUE COULD POTENTIALLY ALLOW AN INCORRECT PATIENT RESULT TO BE VALIDATED AND REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072969 ↗
• MalfunctionMay 12, 2023Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY ENCOUNTERED AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE CUSTOMER WAS MANUALLY VALIDATING A SET OF RESULTS ASSOCIATED WITH A FIRST PATIENT IN THE COBAS INFINITY SOFTWARE. THE RESULTS FOR THIS FIRST PATIENT APPEARED TO HAVE CHANGED OVER TO "VALIDATED" IN THE SOFTWARE AND THEN THE PATIENT DEMOGRAPHICS UPDATED TO A SECOND PATIENT. WHEN THE PATIENT DEMOGRAPHICS WERE UPDATED, THE ASSOCIATED TEST RESULTS SHOULD HAVE BEEN UPDATED TOO, BUT THE SECOND PATIENT'S DEMOGRAPHICS WERE ASSOCIATED WITH THE FIRST PATIENT'S RESULTS. THE USER WAS USING THE "VALIDATE ALL" FUNCTION WITHIN THE MAIN>WORK AREAS>PATIENT REPORTS SCREEN OF THE SOFTWARE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE ORDER ID, (B)(6), WHICH HAD A LACTIC ACID RESULT THAT WAS VALIDATED. THE DEMOGRAPHICS UPDATED AND POPULATED THE ORDER ID OF THE NEXT PATIENT, (B)(6). ORDER ID (B)(6) SHOULD HAVE DISPLAYED A VANCOMYCIN RESULT, HOWEVER, THE LACTIC ACID RESULT FROM ID (B)(6) STAYED ON THE SCREEN AND APPEARED LINKED WITH ORDER ID (B)(6). THE USER BACKED OUT OF THE WORK AREAS SCREEN AND WENT BACK IN. WHEN THE USER WENT BACK INTO THE SCREEN, THE ANTICIPATED VANCOMYCIN RESULT WAS THEN DISPLAYED FOR ORDER ID (B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919303 ↗
• MalfunctionFeb 13, 2023Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF INSTRUMENT FLAGS AND ALARMS BEING REMOVED BY ANALYZER SOFTWARE AFTER RESULT MODIFICATION BY THE RULES ENGINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368259 ↗
• MalfunctionFeb 1, 2023Application Program Problem; Application Program Problem

  IT WAS ALLEGED THAT THE COBAS INFINITY SYSTEM REMOVED DATA FLAGS/ALARMS ATTACHED TO RESULTS TRANSMITTED FROM AN INSTRUMENT AFTER A RULE FROM THE COBAS INFINITY SYSTEM MODIFIES THE RESULT. AN AST VALUE OF 0 WAS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS). THIS 0 VALUE WAS ALLEGEDLY REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN SINCE OTHER LIVER ENZYMES WERE REALLY HIGH FOR THIS PATIENT. THE SAMPLE WAS REPORTEDLY REPEATED WITH DILUTION AND THE AST RESULT WAS 10208. THE UNITS OF MEASURE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280713 ↗
• MalfunctionDec 12, 2022Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY HAVE AN ISSUE WITH THE COBAS INFINITY SOFTWARE USING WITH COBAS INFINITY MICROBIOLOGY LAB MODULE S, SERIAL NUMBER 48003619OM4MI. THERE WAS A MISMATCH OF THE ANTIBIOGRAM RESULTS BETWEEN THE REPORTS FROM TWO DIFFERENT PATIENTS THAT WERE GENERATED USING AN EXTERNAL WEBSERVICE. THE CUSTOMER PROVIDED AN EXAMPLE OF A QUESTIONABLE REPORT VERSUS THE EXPECTED REPORT FOR ONE PATIENT: THE QUESTIONABLE REPORT CONTAINED THE FOLLOWING INFORMATION: AMOXICILINA-CLAVULANICO = S, AMPICILINA/AMOXICILINA = R, PIPERACILINA-TAZOBACTAM = NO RESULT PROVIDED, MEROPENEM = NO RESULT PROVIDED, CEFUROXIMA = S, CEFTAZIDIMA = NO RESULT PROVIDED, CEFEPIME = NO RESULT PROVIDED, NORFLOXACINO = S, CIPROFLOXACINO = S, TOBRAMICINA = NO RESULT PROVIDED, CORTRIMOXAZOL = S, FOSFOMICINA = S, FURANTOINA = S. THE EXPECTED REPORT CONTAINED THE FOLLOWING INFORMATION: PIPERACILINA-TAZOBACTAM = S, MEROPENEM = S, CEFTAZIDIMA = S, CEFEPIME = S, CIPROFLOXACINO = R, TOBRAMICINA = S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959685 ↗
• MalfunctionNov 9, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY CORE LICENSE. THE CUSTOMER REPORTED THAT THE ORDER RECEIVED FROM AN EXTERNAL HOST WAS ASSIGNED INCORRECTLY TO A SAMPLE ID THAT WAS EXPECTED FOR ANOTHER PATIENT. ACCORDING TO THE MEDICAL TECHNICIAN, THE RELATED SERVICE IN THE HOSPITAL REPORTED THAT NEWBORN PATIENT RESULTS WERE NOT FOUND IN THE HEALTH INFORMATION SYSTEM (HIS). WHEN THE LABORATORY PERSONNEL LOOKED FOR THE RESULTS THEY FOUND THAT THE ORDER WAS RELATED TO ANOTHER PATIENT'S INFORMATION AND TESTS. THE SOFTWARE VERSION IS 2.5.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761684 ↗
• MalfunctionNov 7, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF INCORRECT RESULTS BEING GENERATED DUE TO AN ISSUE WITH THE COBAS INFINITY. AN INSTRUMENT TYPE RULE THAT SHOULD HAVE BEEN EXECUTED ONLY FOR RESULTS WITH AN ALARM 26 WAS EXECUTED WITHOUT THIS ALARM AND CAUSED THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) TO RECEIVE RESULTS FOR TESTS THAT WERE NOT DOSED ON THE INSTRUMENT. FOR ONE PATIENT, A TSH TEST WAS NOT PERFORMED ON THE INSTRUMENT, BUT A RESULT OF 100 WAS SENT TO THE CUSTOMER'S LIS. NO UNIT OF MEASURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745373 ↗
• MalfunctionOct 4, 2022Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY HAVE AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE COBAS INFINITY SOFTWARE IS NOT CORRECTLY PROCESSING TEST RESULTS RECEIVED THROUGH THE DRIVER 281.1 FROM THE URISYS INSTRUMENT. WHEN A DECIMAL RESULT IS RECEIVED (E.G. 1.005), THE COBAS INFINITY SOFTWARE PROCESSES AND SAVES THE RESULT, REMOVING THE DECIMAL POINT, WHICH RESULTS IN AN INTEGER RESULT (E.G. 1005).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537954 ↗
• MalfunctionAug 26, 2022Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY HAVE AN ISSUE WITH THE COBAS INFINITY SOFTWARE. FOR ONE PATIENT, A TEST RESULT WAS BEING SAVED ERRONEOUSLY IN THE COBAS INFINITY SOFTWARE. A URINE GLUCOSE VALUE WAS SAVED AS A 24 HOUR URINE GLUCOSE VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303209 ↗
• MalfunctionJun 27, 2022Application Program Problem; Application Program Problem

  THE CUSTOMER STATES THERE IS AN ISSUE WITH THE COBAS INFINITY SOFTWARE THAT ALLOWS TEST RESULTS TO VALIDATED AND RELEASED BEFORE THE SYSTEM PERFORMS CORRESPONDING QUALITY CONTROL EVALUATION. CONSEQUENTLY, PATIENT RESULTS WILL NOT BE LINKED WITH QUALITY CONTROL RESULTS AND WILL HAVE A STATUS INDICATING THAT QUALITY CONTROL RESULTS ARE PENDING. THE CUSTOMER SET UP THE TRIGGERING OF A RULE IN THE COBAS INFINITY SYSTEM TO "AFTER RESULT EVALUATION", WHICH MEANS THAT THE RULE IS TO BE TRIGGERED ONLY AFTER QUALITY CONTROL, AVERAGE OF NORMALS, AND SERUM INDICES HAVE BEEN EVALUATED FOR SAMPLE TEST RESULTS. WHEN USING THE "AFTER RESULT EVALUATION" SETTING, IT WAS FOUND THAT RULES WOULD BE TRIGGERED IN THE COBAS INFINITY SYSTEM BEFORE THE QUALITY CONTROL EVALUATION OF SOME TESTS PERFORMED FOR A SAMPLE. THE CUSTOMER EXPECTED INDIVIDUAL TEST RESULTS FOR A PATIENT SAMPLE TO BE VALIDATED ONLY AFTER THE QUALITY CONTROL EVALUATION HAS BEEN PERFORMED, BUT THIS WAS NOT THE CASE. THE COBAS INFINITY WOULD TRIGGER THE RULE FOR ALL TESTS WITH RESULTS BELONGING TO THE TEST GROUP ASSIGNED TO THE RULE. WHEN THIS OCCURS, THE RULE WOULD BE TRIGGERED FOR SOME SAMPLE TEST RESULTS EVEN IF QUALITY CONTROLS FOR TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829856 ↗
• MalfunctionJun 24, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A PATIENT DEMOGRAPHIC MISMATCH FROM THE COBAS INFINITY. THE SAMPLES WERE NOT CENTRIFUGED WHICH ALERTED THE LABORATORY STAFF THAT THE SAMPLES WERE NOT PROCESSED CORRECTLY. THE LABORATORY TECH THEN NOTICED THE PATIENT NAME DISPLAYED ON THE 8100 COMMAND UNIT DIFFERED FROM THE PATIENT NAME ON THE PRINTED LABELS. IN THE 8100 COMMAND UNIT, SAMPLE ID (B)(6) WAS INCORRECTLY ASSOCIATED WITH PATIENT 1. THREE BARCODE LABELS WITH SAMPLE ID (B)(6) HAD THE NAME OF PATIENT 2. THE CUSTOMER CONFIRMED THE TESTS, SAMPLE ID, AND RESULTS ARE ALL THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802967 ↗
• MalfunctionJun 14, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH THE COBAS INFINITY CORE SOFTWARE. THE CUSTOMER PROVIDED TWO SETS OF QUESTIONABLE BUN RESULTS FOR ONE PATIENT. IT WAS REPORTED THE PATIENT'S BUN RESULT ON THE ROCHE ANALYZER WAS 110.7 WITH A DATA FLAG. THE PATIENT'S BUN RESULT IN THE COBAS INFINITY CORE SOFTWARE WAS 112 WITH A DATA FLAG. IT WAS REPORTED THE PATIENT'S BUN RESULT ON THE ROCHE ANALYZER WAS 115.4 WITH A DATA FLAG. THE PATIENT'S BUN RESULT IN THE COBAS INFINITY CORE SOFTWARE WAS 10,080 WITH A DATA FLAG. REPORTEDLY THE BUN RESULTS FROM THE ROCHE ANALYZER WERE CORRECT AND WERE SENT TO THE COBAS INFINITY CORE SOFTWARE CORRECTLY. THE UNITS OF MEASUREMENT WERE REQUESTED BUT NOT PROVIDED. THE TYPE OF ROCHE ANALYZER USED FOR TESTING WAS REQUESTED BUT NOT PROVIDED. THE BUN REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684161 ↗
• MalfunctionJun 8, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE OF MISSING RESULT FLAGS ON THREE SEPARATE OCCASIONS WITH THE COBAS INFINITY CORE SOFTWARE. THE CUSTOMER PROVIDED AN EXAMPLE OF MISSING RESULT FLAGS FOR ONE PATIENT: THE CUSTOMER PERFORMED PATIENT TESTING ON A COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4). REPORTEDLY THE PATIENT'S INITIAL RESULTS WERE URINE TOTAL PROTEIN <0.07 G/L AND URINE CREATININE <0.1 MMOL/L WITH NO ALARM CODES OR FLAGS. THESE RESULTS WERE RELEASED FROM THE COBAS INFINITY CORE SOFTWARE AND REPORTED OUTSIDE THE LABORATORY. BASED ON THE INITIAL TOTAL PROTEIN AND CREATININE RESULTS, ALLEGEDLY THE RESULTS WERE MISSING DATA FLAGS. THE TOTAL PROTEIN URINE/CSF REAGENT LOT NUMBER WAS 570146 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED. THE CREP2 CREATININE PLUS VER.2 REAGENT LOT NUMBER WAS 591139 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630922 ↗
• MalfunctionMay 25, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A TEST FIELD (MASK) MISMATCH WITH THE COBAS INFINITY SOFTWARE. THE CUSTOMER USES THE TEST FIELD FUNCTION OF THE REPORT DESIGN IN THE COBAS INFINITY SOFTWARE TO ADD TEST REFERENCE RANGES AND UNITS OF MEASUREMENT. IT WAS REPORTED THAT WHEN THE TEST FIELD TEXT (REFERENCE RANGES) FOR AN ASSAY WAS UPDATED, THE REFERENCE RANGES FOR PREVIOUS RESULTS WERE AUTOMATICALLY UPDATED TO THE UPDATED REFERENCE RANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496529 ↗
• MalfunctionMay 9, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE COBAS INFINITY SOFTWARE THAT COULD LEAD TO ERRONEOUS RESULTS. THE RESULT WAS INITIALLY SENT FROM THE INFINITY SOFTWARE TO TRAKCARE CORRECTLY. THE TRAKCARE DID NOT ACCEPT THE RESULT FOR HCV AND TOXO IGM. WHEN THE RESULT WAS RESENT FROM THE COBAS C8000 ANALYZER, THE INFINITY RULE THAT CHANGES THE RESULT TO "N" OR "P" WAS NOT TRIGGERED EVEN THOUGH IT IS SET TO DO SO ON REPEATED EXECUTION. THE RESULTS WERE SENT TO THE LIS WITHOUT THE RULE ENGINE TRANSFORMATION APPLIED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14335266 ↗
• MalfunctionFeb 17, 2022Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH THE COBAS INFINITY SOFTWARE. AN AST TEST RESULT FOR A PATIENT SAMPLE WAS AUTOMATICALLY VALIDATED IN THE COBAS INFINITY SOFTWARE DUE TO A MISSING FLAG AND THE RESULT WAS RELEASED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE RESULT SHOULD HAVE BEEN BLOCKED BY THE COBAS INFINITY SOFTWARE FOR MANUAL VALIDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549808 ↗
• MalfunctionSep 1, 2021Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  THE INITIAL REPORTER STATES THERE IS AN ISSUE WITH THEIR COBAS INFINITY SOFTWARE. A RULE WAS CREATED IN THE COBAS INFINITY SOFTWARE TO BLOCK TEST RESULTS MARKED WITH A FLAG INDICATING THAT THE SAMPLE IS HEMOLYTIC. THE REPORTER STATES THAT THE RULE IS TRIGGERED SOMETIMES AND SOMETIMES NOT. WHEN THE RULE IS NOT TRIGGERED, THE SOFTWARE WILL NOT BLOCK THE RESULT AND THE RESULT IS SENT TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408966 ↗
• MalfunctionJul 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INIFINITY SOFTWARE. THE COBAS INFINITY SOFTWARE IS NOT USING PREVIOUS SAMPLE RESULTS FROM A PATIENT IN ORDER TO CALCULATE A DELTA CHECK. AS A RESULT, SAMPLE RESULTS THAT SHOULD BE FLAGGED WITH A DELTA CHECK ALARM ARE NOT BEING FLAGGED WITH A DELTA CHECK ALARM. IT WAS ASKED, BUT NOT KNOWN IF ANY INCORRECT PATIENT VALUES WERE GENERATED DUE TO THE ISSUE. THE COBAS INFINITY SOFTWARE SOFTWARE IS CURRENTLY NOT BEING USED AT THE CUSTOMER SITE FOR DIAGNOSTIC PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233448 ↗
• MalfunctionJul 14, 2021Application Program Problem; Insufficient Device Problem Information; Application Program Problem; Insufficient Device Problem Information

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. RESULTS FLAGGED FOR HEMOLYSIS WERE RELEASED OUTSIDE OF THE LABORATORY, BUT SHOULD HAVE BEEN HELD IN THE COBAS INFINITY SOFTWARE. THE REPORTER STATED THE ISSUE OCCURRED WITH SIX PATIENT SAMPLES. AN EXAMPLE FOR ONE PATIENT SAMPLE WAS PROVIDED. A HEMOLYTIC PATIENT SAMPLE WAS TESTED FOR TROPONIN T ON AN ANALYZER AND THE RESULT WAS 0.004 NG/ML. THE RESULT FROM THE ANALYZER INDICATED THE SAMPLE WAS HEMOLYTIC. WHEN THE RESULT WAS RECEIVED BY THE COBAS INFINITY SOFTWARE, IT CONVERTED THE TROPONIN T VALUE TO < 0.010 AND RELEASED THIS VALUE OUTSIDE OF THE LABORATORY BEFORE COMPLETION OF THE RULE ENGINE THAT DESIGNATES THE SAMPLE AS HEMOLYZED. THE COBAS INFINITY SOFTWARE SHOULD HAVE BLOCKED THE RESULT FROM BEING RELEASED AND SENT A FLAG OF "GUH" TO THE CUSTOMER'S HOST SYSTEM, WHICH INDICATES "NO RESULT - HEMOLYTIC SAMPLE". THE REPORTER INDICATED THE RULE IN THE COBAS INFINITY SOFTWARE WAS WORKING CORRECTLY, BUT NOT EXECUTED IN A TIMELY MANNER, ALLOWING THE RESULT TO BE RELEASED TO THE CUSTOMER'S HOST SYSTEM BEFORE THE HEMOLYSIS FLAGGING COULD TRIGGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166518 ↗