cobas® infinity central lab 09180443001Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613336177129), received between Sep 15, 2021 and Nov 26, 2025 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE ISSUE AFFECTED PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE RESULT MODIFICATION RULES SET UP ON THE COBAS INFINITY SOFTWARE FOR THE ANTI-HAV ASSAY WERE FOUND TO BE INCORRECT. ACCORDING TO PRODUCT LABELING FOR THE ANTI-HAV ASSAY, PATIENT RESULTS WITH RESULTS > 1.0 COI ARE INTERPRETED AS NON-REACTIVE. PATIENT RESULTS WITH RESULTS < OR = TO 1.0 COI ARE INTERPRETED AS REACTIVE. THE COBAS INFINITY SOFTWARE WAS SET UP TO MODIFY RESULTS FROM THE E 801 ANALYZERS TO PROVIDE THE FOLLOWING RESULT INTERPRETATIONS: COI VALUES OF -99999 TO 0.90 = NON-REACTIVE, COI VALUES OF 0.90 TO 1.09 = EQUIVOCAL, COI VALUES OF 1.10 TO 999999 = REACTIVE. THE ISSUE HAS IMPACTED APPROXIMATELY 167 PATIENT SAMPLES THAT HAVE BEEN TESTED SINCE (B)(6) 2025. FOR EXAMPLE, A SAMPLE TESTED ON AN E 801 ANALYZER ON (B)(6) 2025 RESULTED IN AN ANTI-HAV VALUE OF 1.06 COI. THE VALUE SHOULD HAVE BEEN INTERPRETED AS NON-REACTIVE, BUT BASED ON THE RESULT MODIFICATION RULES SET UP IN COBAS INFINITY, THE RESULT WAS REPORTED AS EQUIVOCAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657929 ↗
• MalfunctionOct 16, 2025Application Program Problem; Application Program Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH THE COBAS INFINITY LAB CORE LICENSE VERSION 3.10.03. THE CUSTOMER ALLEGED THAT AN INCORRECT PATIENT RESULT WAS DISPLAYED FROM THE PATIENT HISTORY TAB. THE CUSTOMER WAS CHECKING THE PATIENT RESULT HISTORY TAB FOR A PATIENT; HOWEVER, THE RESULTS SHOWN WERE FOR A DIFFERENT PATIENT. THE PATIENT WAS NOT HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310264 ↗
• MalfunctionJul 25, 2025Application Program Problem; Application Program Problem

  WE RECEIVED AN ALLEGATION OF AN ISSUE WITH THE COBAS INFINITY LAB CORE LICENSE SOFTWARE VERSION 3.03.15. THE CUSTOMER ALLEGED THAT THE SOFTWARE OVERCALCULATED THE VALUE FOR THE EOSINOPHILS TEST, RESULTING IN AN INCORRECT RESULT. ALLEGEDLY, AFTER COMPLETING THE VALIDATION AND TRANSMISSION PROCESS, THE ORIGINAL RESULT IS TRANSMITTED FROM THE INSTRUMENT AGAIN AS A MULTIPLIED RESULT. THIS SIGNIFICANTLY HIGHER RESULT IS NOT VALIDATED, AS IT IS NOT COMPATIBLE WITH THE OTHER RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608831 ↗
• MalfunctionJun 6, 2025Application Program Problem; Application Program Problem

  WE RECEIVED AN ALLEGATION OF A SOFTWARE MALFUNCTION IN THE COBAS INFINITY LAB CORE LICENSE 3.X. THE REPORTER STATED THAT THE PATIENT'S HISTORY TAB SHOWS INCORRECT INFORMATION (FROM A DIFFERENT PATIENT), WHICH AFFECTS MEDICAL VALIDATION. THERE WAS NO REPORT OF ANY PATIENT HARM BECAUSE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158270 ↗
• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem

  THE INITIAL REPORTER ALLEGED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. A RULE WAS CREATED IN THE COBAS INFINITY SOFTWARE TO TRANSMIT RESULTS LESS THAN THE MEASURING RANGE OF THE ASPARTATE AMINO TRANSFERASE (AST) ASSAY (MEASURING RANGE = 5 - 700 U/L) AS < 5 U/L. A SAMPLE PROCESSED ON A COBAS C 503 ANALYTICAL UNIT INITIALLY RESULTED IN AN AST VALUE OF 55.5 U/L ACCOMPANIED BY A DATA FLAG INDICATING A LINEARITY ISSUE. THE SAMPLE WAS THE AUTOMATICALLY DILUTED 1:10 ON THE C 503 ANALYZER AND REPEATED, RESULTING IN AN AST VALUE OF 43.3 U/L WITH A DATA FLAG INDICATING THE VALUE WAS BELOW THE MEASURING RANGE OF THE ASSAY. THE RESULT OF 43.3 U/L WAS TRANSMITTED TO THE CUSTOMER'S HOST SYSTEM BY THE COBAS INFINITY SOFTWARE AS < 5 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872741 ↗
• MalfunctionApr 1, 2025Computer Software Problem; Computer Software Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH COBAS INFINITY LAB CORE LICENSE SOFTWARE VERSION 3.02.09. THE CUSTOMER ALLEGED THAT A SAMPLE CAME IN FOR ONE PATIENT (PATIENT (B)(6) BUT WAS ASSIGNED TO A DIFFERENT PATIENT (PATIENT (B)(6). NO PATIENTS WERE HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739799 ↗
• MalfunctionDec 3, 2024Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH THE COBAS INFINITY SOFTWARE VERSION 3.05.07. THE CUSTOMER ALLEGED THAT THE COBAS INFINITY SYSTEM DISPLAYED INCORRECT PATIENT INFORMATION ON THE VALIDATION SCREEN. INFORMATION FOR A DIFFERENT PATIENT IS SHOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832433 ↗
• MalfunctionNov 19, 2024Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH COBAS INFINITY LAB CORE LICENSE VERSION 3.03.24. THE COBAS INFINITY SOFTWARE ALLOWS THE CREATION OF CUSTOMIZED RULES. THE RULES ARE CONFIGURATIONS OF CONDITIONS AND ACTIONS RELATED TO ORDERS, TESTS, TUBES, OR INSTRUMENTS. THE SOFTWARE AUTOMATICALLY TRIGGERS THE CORRESPONDING ACTIONS IF CERTAIN CONDITIONS ARE MET. IN THIS CASE, THE CUSTOMER ALLEGED THAT A SOFTWARE RULE WAS NOT EXECUTED DUE TO A MISSING INSTRUMENT ALARM. NO PATIENTS WERE HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723480 ↗
• MalfunctionSep 20, 2024Computer Software Problem; Computer Software Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE COBAS INFINITY LAB CORE SOFTWARE THAT OCCURRED FOUR TIMES. THE CUSTOMER ALLEGED THAT THE RESULTS DISPLAYED IN THE VALIDATION PANE DID NOT MATCH THE RESULTS IN THE CORRESPONDING COLUMN IN THE PATIENT HISTORY TAB. THE CUSTOMER ALLEGED THE DATA BEING PULLED IS BEING CARRIED OVER FROM THE LAST RECORD VIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267824 ↗
• MalfunctionJul 3, 2024Application Program Problem; Application Program Version or Upgrade Problem; Application Program Problem; Application Program Version or Upgrade Problem

  THERE WAS AN ALLEGATION OF INCORRECT RESULTS IN THE COBAS INFINITY LAB CORE SOFTWARE AFTER OPTIMIZATION. THE RESULTS FOR TACROLIMUS WERE ASSIGNED TO THE AHIV TEST FOR PATIENT SAMPLES. ONE EXAMPLE WAS PROVIDED OF AN ORIGINAL TACROLIMUS RESULT OF 6.520 PG/ML. AFTER OPTIMIZATION, THE RESULT WAS 6.520 PG/ML FOR THE TEST AHIV. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CORRECT RESULTS WERE IN THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667442 ↗
• MalfunctionJul 1, 2024Application Program Problem; Application Program Version or Upgrade Problem; Application Program Problem; Application Program Version or Upgrade Problem

  THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH THE COBAS INFINITY SOFTWARE. WITH THE SOFTWARE VERSION 3.05.05, THE CUSTOMER ENCOUNTERED AN ISSUE WITH QC BRACKETING. WHEN THE COBAS INFINITY SOFTWARE RECEIVES PATIENT RESULTS THAT WERE MEASURED BETWEEN A GOOD QC AND A BAD QC, THE COBAS INFINITY SOFTWARE WILL REMOVE QC BRACKETING (QCB) FLAGS FROM THE RESULTS ONCE GOOD QC IS OBTAINED. THIS OCCURS WITH BOTH INITIAL AND REPEAT PATIENT RESULTS. THE COBAS INFINITY SOFTWARE IS EXPECTED TO NOT REMOVE THE QC BRACKETING FLAGS FROM RESULTS IN THIS SCENARIO. WHEN PATIENT RESULTS ARE FLAGGED WITH QCB, THE RELEASE OF THESE RESULTS TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM IS PREVENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642971 ↗
• MalfunctionMar 28, 2024Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH COBAS INFINITY LAB CORE LICENSE SOFTWARE VERSION 3.03.08. THE CUSTOMER HAS A RULE CONFIGURED TO REPEAT A TEST IF A SPECIFIC RESULT WAS RECEIVED. THE CUSTOMER ALLEGED THE RULE TRIGGERING REPEAT TESTING WAS NOT EXECUTED CAUSING THE INTERIM RESULT TO BE SENT TO THE EXTERNAL HOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994598 ↗
• MalfunctionFeb 9, 2024Computer Software Problem; Program or Algorithm Execution Problem; Computer Software Problem; Program or Algorithm Execution Problem

  WE RECEIVED AN ALLEGATION OF A SOFTWARE MALFUNCTION IN THE COBAS INFINITY LAB CORE LICENSE 3.X. THE REPORTER STATED THAT THE RULE THAT ADDS A RESULT TO TEST NUMBER 55 (HCV-RES) AND DELETES THE TESTS HCV-VAL AND HCV-LOG WAS NOT EXECUTED AND AN INCORRECT RESULT WAS RELEASED TO THEIR LABORATORY INFORMATION SYSTEM (LIS). THE REPORTER DETECTED THE ISSUE IN THE LIS; NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675954 ↗
• MalfunctionJan 9, 2024Application Program Problem; Data Problem; Application Program Problem; Data Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE REPORTER ALLEGES THAT THE RAW RESULT FIELD DOES NOT CONSISTENTLY REFLECT THE VALUE SENT BY A COBAS C8800 INSTRUMENT. THE VALUE SENT FROM THE INSTRUMENT IS INCORRECTLY DISPLAYED WHEN VIEWED IN THE COBAS INFINITY SOFTWARE. THE EXPONENTIAL COMPONENT OF THE RESULT SENT BY THE C8800 INSTRUMENT IS NOT REFLECTED IN THE COBAS INFINITY SOFTWARE. TWO EXAMPLES OF INCORRECT PATIENT DATA WERE PROVIDED. FOR THE FIRST EXAMPLE, THE INSTRUMENT WILL TRANSMIT A VALUE OF 104 X 10^0 COPIES/ML. IN THE COBAS INFINITY VALIDATION SCREEN, THE TEST RESULT FIELD IS DISPLAYED AS "104" AND THE RAW RESULT FIELD IS DISPLAYED AS 104 COPIES/ML. FOR THE SECOND EXAMPLE, THE INSTRUMENT WILL TRANSMIT A VALUE OF 219 X 10^-1 COPIES/ML. IN THE COBAS INFINITY VALIDATION SCREEN, THE TEST RESULT FIELD IS DISPLAYED AS "21.9" AND THE RAW RESULT FIELD IS DISPLAYED AS 214 COPIES/ML. A RESULT MODIFIER RULE SET UP IN THE INSTRUMENT CONNECTIVITY AGENT (ICA) OF THE COBAS INFINITY SOFTWARE CONVERTS RESULTS OF < 50 TO A LIMIT RESULT OF "< 50". IN THIS EXAMPLE, THE USER DOES NOT SEE 21.9 AS THIS IS CONVERTED BY THE ICA TO < 50. THE RAW RESULT FIELD IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476832 ↗
• MalfunctionJan 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  WE RECEIVED AN ALLEGATION OF A SOFTWARE MALFUNCTION IN THE COBAS INFINITY LAB CORE LICENSE 3.X. THE REPORTER STATED THAT THE INSTRUMENT DRIVER WAS SAVING A RESULT IN THE FIELD "R4" INSTEAD OF THE FIELD "R4-1"; THE DRIVER WAS SAVING "62.42^" INSTEAD OF "62.42". THERE WAS NO REPORT OF ANY PATIENT HARM BECAUSE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476660 ↗
• MalfunctionJan 8, 2024Application Program Problem; Data Problem; Application Program Problem; Data Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY LAB CORE LICENSE 3.X. THE REPORTER INDICATED THE SYSTEM WAS NOT DISPLAYING THE UNIT OF MEASURE FOR THE PREVIOUS RESULT ON THE VALIDATION SCREEN. THE UNIT OF MEASURE IS ONLY VISIBLE FOR THE CURRENT VALUE. WHEN CONNECTED TO THE COBAS 8800 MODULE, QUANTITATIVE RESULTS WITH 3 OR MORE DIGITS ARE EXPRESSED IN THE FORM "3 DIGITS + 10*X IU/ML". THE SOFTWARE VERSION IS 3.05. NO PATIENT WAS HARMED DUE TO THE ISSUE. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467425 ↗
• MalfunctionJan 4, 2024Application Program Problem; Application Program Problem

  WE RECEIVED AN ALLEGATION OF A SOFTWARE MALFUNCTION IN THE COBAS INFINITY LAB CORE LICENSE 3.X. THE REPORTER STATED THAT THE INSTRUMENT DRIVER DID NOT REPLACE AN EMPTY RESULT BY A DEFINED EQUIVALENCE AND AS A CONSEQUENCE, A SERIES OF RULES WERE TRIGGERED BECAUSE THE RESULT REMAINED EMPTY. THERE WAS NO REPORT OF ANY PATIENT HARM BECAUSE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445733 ↗
• MalfunctionOct 20, 2023Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE CUSTOMER ALLEGED THAT PATIENT RESULTS OBSERVED IN THE EVOLUTION (VALIDATION), PATIENT HISTORY (VALIDATION), AND HISTORY/EVOLUTION CHARTS (ORDER SEARCH) SECTIONS OF THE COBAS INFINITY SOFTWARE ARE NOT PRESENTED IN A CHRONOLOGICALLY CORRECT ORDER. THE SOFTWARE USES THE ORDER CREATION DATE INSTEAD OF THE SAMPLE COLLECTION DATE TO PLACE SAMPLES IN CHRONOLOGICAL ORDER. THE CUSTOMER ALLEGES THIS COULD POSSIBLY GIVE A MISLEADING PICTURE OF THE PATIENT'S PROGRESS TO THE CLINICIANS REVIEWING THE SAMPLE RESULTS THROUGH THE EVOLUTION, PATIENT HISTORY, OR HISTORY SECTIONS OF THE SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977055 ↗
• MalfunctionOct 6, 2023Application Program Problem; Application Program Problem

  THE INITIAL REPORTER ALLEGED THAT COMMENTS THAT CONTAIN INFORMATION NEEDED FOR THE INTERPRETATION OF ASSOCIATED RESULTS ARE MISSING IN THE COBAS INFINITY LAB CORE LICENSE 3.X.. THE REPORTER STATED THAT THE MISSING ISERUM INDICES (SI) VALUES IN THE INTERFERENCE TABLE PREVENTED THE ADDITION OF INTERPRETATION COMMENTS TO THE PATIENT RESULTS. THE VALUES WERE REPORTEDLY PRESENT IN THE TEST SERVER, BUT WHEN THE CONFIGURATION WAS IMPORTED TO THE PRODUCTION SERVER FROM THE TEST, THE VALUES WERE MISSING. THERE WAS NO REPORT OF ANY PATIENT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17891787 ↗
• MalfunctionJul 19, 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 RULE TO DELETE A SPECIFIC TEST (HIV2) WHEN A SPECIFIC RESULT (NON-REACTIVE) WAS RECEIVED. THIS RULE IS TRIGGERED WHEN A RESULT IS RECEIVED FROM THE INSTRUMENT. THE REPORTER STATED THAT FOR ONE CASE, THIS RULE WAS NOT TRIGGERED AND THE TEST WAS NOT DELETED. THE REPORTER DETECTED THE ISSUE WHEN THE RESULT WAS INCORRECTLY EXPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356583 ↗
• InjuryMar 15, 2023Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A POSITIVE HIV RESULT BEING INTERPRETED AS NEGATIVE ON THE COBAS INFINITY CORE SOFTWARE FOR 1 PATIENT SAMPLE. IT WAS ALLEGED THAT ON (B)(6) 2022, A PATIENT WAS TESTED FOR HIV. THE RESULT WAS ALLEGEDLY REPORTED IN THE INFINITY SOFTWARE AS NEGATIVE AND THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. AFTER THE PATIENT¿S PARTNER WAS DETERMINED TO BE HIV POSITIVE, THE PATIENT UNDERWENT FURTHER TESTING. IN FEB 2023, THE PATIENT WAS TESTED AT ANOTHER LABORATORY AND FOUND TO BE HIV POSITIVE. THE ORIGINAL REPORTING LABORATORY WAS RECENTLY INFORMED OF THE NEW PATIENT RESULT AND INVESTIGATED THE DISCREPANCY.

  Patient problems: Viral Infection

  MAUDE report 16548129 ↗
• MalfunctionDec 19, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY CORE SOFTWARE, VERSION 3.03.11. THERE WAS REPORTEDLY A DELAY WITH RULE ENGINE EXECUTION OF TEN SECONDS TO 1.5 HOURS WHICH CAUSES INCORRECT RESULTS TO BE VALIDATED AND RELEASED TO THE LABORATORY INFORMATION SYSTEM (LIS). IT HAS BEEN CONFIRMED THAT NO PATIENT WAS HARMED BECAUSE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009499 ↗
• MalfunctionDec 9, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY CORE SOFTWARE. THE REPORTER STATED THAT A RESULT HAS BEEN RELEASED BY THE SOFTWARE WHICH SHOULD HAVE BEEN HELD BY A DELTA CHECK FLAG. THE REPORTER NOTICED THAT FOR THEIR PATIENT THAT HAD AN INITIAL AND REPEAT SAMPLE, THE REPEAT RESULT HAD A DELTA FLAG AND WAS HELD, BUT THE INITIAL RESULT WAS RELEASED BY THE SOFTWARE AND THEN HELD BY THE LABORATORY INFORMATION SYSTEM (LIS). THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949348 ↗
• MalfunctionOct 19, 2022Application Program Problem; Application Program Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COBAS INFINITY SOFTWARE. THE NAME OF A DIFFERENT PATIENT APPEARED FOR SAMPLE INFORMATION FROM A SECOND PATIENT. IT WAS OBSERVED THAT ON (B)(6) 2022, THE COBAS INFINITY SOFTWARE RECEIVED DATA FOR PATIENT IDENTIFIER "(B)(6)" WHERE THE INITIALS OF THE PATIENT'S NAME ARE "CDMM". ON (B)(6) 2022, DATA WAS RECEIVED FROM THE SAME PATIENT IDENTIFIER "(B)(6)" BUT THE INITIALS OF THE PATIENT'S NAME WERE "(B)(6)." WHEN INVESTIGATING THE TRACE LOG FROM COBAS INFINITY IT WAS POSSIBLE TO SEE SAMPLES THAT HAVE BEEN RECEIVED AND OTHERS THAT HAVE BEEN REJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635333 ↗
• MalfunctionAug 11, 2022Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS INFINITY CORE SOFTWARE. AFTER UPGRADING TO THE NEW VERSION OF INFINITY SOFTWARE, THE CUSTOMER'S REFERENCE RANGES FOR HDL AND LDL TESTS ARE NOT CORRECTLY BEING SENT TO THE CUSTOMER'S LIS (LABORATORY INFORMATION SYSTEM). THIS ISSUE CAUSES INCORRECT INFORMATION ON THE CUSTOMER'S REPORTS. NO PATIENT WAS AFFECTED BY THE ISSUE. THE ISSUE WAS DETECTED IN A TEST ENVIRONMENT. THE SOFTWARE VERSION IS 3.03.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213873 ↗