cobas 8000 Core Unit 05641446001Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04015630928330), received between Jul 12, 2018 and Jul 3, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE ON A COBAS 8000 CORE UNIT. ON (B)(6) 2023, IT WAS REPORTED THAT THE COMMUNICATION BETWEEN THE CUSTOMER'S ANALYZER AND THE DATA MANAGER PROGRAM FAILED. THE ANALYZER AND THE DATA MANAGER WERE BOTH RESTARTED, BUT IT DID NOT FIX THE ISSUE. ACCORDING TO THE REPORTER, THE SETTINGS WERE NOT CHANGED BEFORE THE FAILURE OCCURRED. AFTER UNPLUGGING AND PLUGGING IN THE CABLE TO THE DATA MANAGER, THE CUSTOMER RESTARTED THE DATA MANAGER. THE DATA MANAGER STARTED UP, BUT THE DATE DISPLAY DISAPPEARED ON THE SCREEN AND ONLY THE TIME WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250683 ↗
• MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ACTH TEST SYSTEM (ACTH) AND ELECSYS PTH IMMUNOASSAY RESULTS FROM ONE PATIENT'S SAMPLES TESTED ON THE COBAS 8000 CORE UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE PATIENT, WHO HAS BEEN DIAGNOSED WITH PRIMARY HYPERTHYROIDISM AND INFLAMMATORY MYOSITIS WAS NOW PROVISIONALLY DIAGNOSED WITH A PITUITARY TUMOR DUE TO PITUITARY MICROLESIONS. BUT THE TEST RESULTS OVER THE PAST YEAR SHOWED LOW PTH AND ACTH; AND NORMAL LEVELS OF CALCIUM AND PHOSPHORUS. THEY DO NOT BELIEVE THE RESULTS DUE TO THE CLINICAL STATUS OF THE PATIENT. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE QUESTIONABLE RESULTS. THE REAGENT LOT NUMBERS AND THE EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095368 ↗
• MalfunctionDec 1, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH SOFTWARE VERSION 06-07 OF THE COBAS 8000 CORE UNIT. THE COBAS 8000 DATA MANAGER SERIAL NUMBER IS (B)(4). THE CUSTOMER ALLEGED THE USER ID AND CURRENT DATE WERE NOT APPEARING AT THE TOP OF THE SCREEN. CALIBRATION FOR ISE TESTS DID NOT APPEAR IN THE "CALIBRATION > STATUS" AREA EVEN THOUGH THE CALIBRATION HAD BEEN INSTALLED. THE EXPIRATION DATES FOR CALIBRATORS AND QC WERE MISSING FROM THE "CALIBRATION > CALIBRATOR" AND "QC > CONTROLS" AREAS. THE CALIBRATION LOT FOR A RUBELLA IGM REAGENT LOT COULD NOT BE DOWNLOADED. THE CUSTOMER IS ABLE TO RUN SAMPLES BUT IS UNABLE TO INSTALL ANY NEW CALIBRATION AND QC LOTS AND IS UNABLE TO RUN ISE CALIBRATION. THE CUSTOMER NOTICED THAT THE SETTINGS IN THE "UTILITY-SYSTEM" MENU WERE RESET TO DEFAULT SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897199 ↗
• MalfunctionNov 14, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ROCHE DIAGNOSTICS ELECSYS ANTI-TG ON A COBAS 8000 CORE UNIT. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN AN ANTI-TG VALUE OF 196 IU/ML. THIS SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN VALUES OF 327 IU/ML AND 197 IU/ML. THE SECOND SAMPLE INITIALLY RESULTED IN AN ANTI-TG VALUE OF 25 IU/ML. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN VALUES OF 73 IU/ML AND 26 IU/ML. THE THIRD SAMPLE INITIALLY RESULTED IN AN ANTI-TG VALUE OF 55 IU/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 14 IU/ML. THE SAMPLE WAS REPEATED AGAIN ON THE COMPLAINED ANALYZER, RESULTING IN A VALUE OF 14 IU/ML. THE ANTI-TG REAGENT LOT NUMBER WAS 63019101, WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789599 ↗
• MalfunctionNov 8, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS ELECSYS ANTI-TG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. THE INITIAL ANTI-TG PRIMARY TUBE RESULT WAS 39.6 IU/ML. AN ALIQUOT FROM THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS 10 IU/ML WITH FLAG. THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS < 10 IU/ML WITH FLAG. ANOTHER ALIQUOT FROM THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS < 10 IU/ML WITH FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 59537501 AND THE EXPIRATION DATE IS 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754782 ↗
• MalfunctionNov 8, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS ELECSYS ANTI-TG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. THE INITIAL ANTI-TG RESULT WAS 47 IU/ML. AN ALIQUOT FROM THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS 93 IU/ML WITH FLAG. THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS 52 IU/ML WITH FLAG. ANOTHER ALIQUOT FROM THE PRIMARY TUBE WAS REPEATED AND THE RESULT WAS 53 IU/ML WITH FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 59537501 AND THE EXPIRATION DATE IS 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754621 ↗
• MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Chemical Problem; Insufficient Device Problem Information; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Chemical Problem; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. THE INITIAL HCG RESULT WAS 10000 MIU/ML WITH FLAG. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 20.0 MIU/ML WITH FLAG. IT IS NOT KNOWN IF ANY RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754078 ↗
• MalfunctionOct 17, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN SODIUM RESULTS FROM THE COBAS 8000 ANALYZER. SAMPLE 1 INITIAL RESULT WAS 133.88 MMOL/L AND THE REPEAT RESULT WAS 142.76 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 129.57 MMOL/L AND THE REPEAT RESULT WAS 141.21 MMOL/L. SAMPLE 3 INITIAL RESULT WAS 134.65 MMOL/L AND THE REPEAT RESULT WAS 140.59 MMOL/L. SAMPLE 4 INITIAL RESULT WAS 129.47 MMOL/L AND THE REPEAT RESULT WAS 138.23 MMOL/L. SAMPLE 5 INITIAL RESULT WAS 131.16 MMOL/L AND THE REPEAT RESULT WAS 140.52 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ELECTRODE LOT NUMBER WAS Y00 WITH AN EXPIRATION DATE OF 16-MAR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618925 ↗
• MalfunctionSep 20, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FOR 8 PATIENT SAMPLES ON A COBAS 8000 CORE UNIT. SAMPLE 1: THE INITIAL RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. A 1:20 DILUTION WAS PERFORMED AND THE RESULT WAS 15.4 MIU/ML. THE SAMPLE WAS RETESTED AND THE RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. THE REPEATED RESULT WAS 12545 MIU/ML. SAMPLE 2: THE INITIAL RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. A 1:20 DILUTION WAS PERFORMED AND THE RESULT WAS 53.3 MIU/ML. THE SAMPLE WAS RETESTED AND THE RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. THE REPEATED RESULT WAS 48190 MIU/ML. SAMPLE 3: THE INITIAL RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. A 1:20 DILUTION WAS PERFORMED AND THE RESULT WAS 72.2 MIU/ML. THE SAMPLE WAS RETESTED AND THE RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. THE REPEATED RESULT WAS 37854 MIU/ML. THE SAMPLE WAS TESTED AGAIN AND THE RESULT WAS 0.200 MIU/ML WITH A <TEST DATA FLAG. THE REPEATED RESULT WAS 125 MIU/ML. SAMPLE 4: THE INITIAL RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. A 1:20 DILUTION WAS PERFORMED AND THE RESULT WAS 30.6 MIU/ML. THE SAMPLE WAS RETESTED AND THE RESULT WAS 10000 MIU/ML WITH A >TEST DATA FLAG. SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457581 ↗
• MalfunctionMar 9, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS E801 MODULE. THE CUSTOMER IDENTIFIED A CLOGGED SIPPER NOZZLE. AFTER CLEANING THE SIPPER NOZZLE, THE CUSTOMER REPEATED PATIENT SAMPLES AND RECEIVED DIFFERENT RESULTS. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS ANTI-TG (ANTI-TG) AND ELECSYS ANTI-TPO (ANTI-TPO). PATIENT 1 INITIAL ANTI-TG RESULT WAS 139 IU/ML. THE REPEAT RESULT WAS 58.9 IU/ML. PATIENT 2 INITIAL ANTI-TPO RESULT WAS 600 IU/ML. THE REPEAT RESULT WAS 305 IU/ML. PATIENT 3 INITIAL ANTI-TG RESULT WAS 64.5 IU/ML. THE REPEAT RESULT WAS 15.5 IU/ML. PATIENT 3 INITIAL ANTI-TPO RESULT WAS 72.6 IU/ML. THE REPEAT RESULT WAS 9.00 IU/ML WITH A DATA FLAG. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBERS WITH EXPIRATION DATES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712743 ↗
• MalfunctionMar 3, 2022Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH COBAS 8000 DATA MANAGER SERIAL NUMBER (B)(4) ON A COBAS 8000 INSTRUMENT. THE ISSUE WAS NOTICED DURING THE INITIAL CONFIGURATION OF EFLOW TESTS ON THE NEW INSTRUMENT. DURING TESTING TO MAKE SURE THE CONFIGURATION WAS CORRECT, IT WAS NOTED THAT, FOR SOME SAMPLES, WHEN AN (B)(6) DUO RESULT WAS SENT AT THE SAME TIME AS ANOTHER RESULT (E.G. (B)(6)), THE (B)(6 (RESULT WAS DISPLAYED WITHIN THE (B)(6) DUO RESULT. THE DATA MANAGER USES A SPECIFIC COMMUNICATION PROTOCOL TO SEND RESULT MESSAGES TO THE HOST (COBAS INFINITY SOFTWARE). EACH TEST HAS IT¿S OWN "OBR" AND "OBX" SEGMENTS WHICH SHOW THE START AND END OF THE RESULT MESSAGES FOR EACH SPECIFIC APPLICATION. IN THIS CASE, THE (B)(6) DUO RESULT MESSAGE CONTAINING THE MEASURED AND CALCULATED RESULTS STARTED WITH THE "OBR" SEGMENT BUT ALSO HAD MULTIPLE "OBX" SEGMENTS. IN THE EXAMPLE PROVIDED, THE (B)(6) TEST SHOULD START WITH A NEW "OBR" SEGMENT, HOWEVER, IN THIS CASE IT WAS INCLUDED UNDER THE "OBR" SEGMENT OF THE (B)(6) DUO TEST. THE SOFTWARE IS CURRENTLY CONFIGURED AT THE CUSTOMER SITE TO NOT DISPLAY THE RESULTS IF THIS OCCURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660636 ↗
• MalfunctionFeb 2, 2022No Device Output; Patient Data Problem; No Device Output; Patient Data Problem

  THE INITIAL REPORTER ALLEGED A POSSIBLE SAMPLE MISMATCH ISSUE WITH A COBAS 8000 CORE UNIT. THE REPORTER STATED THAT THE PATIENT SAMPLE IDS WERE REUSED AND THE NAMES ON THE PATIENT RESULT PRINTOUTS FROM THE CORE UNIT (CU) WERE INCORRECT. THE INSTRUMENT CU AND RESULT PRINTOUT FROM CU ARE DISPLAYING A PREVIOUS PATIENT NAME. HOWEVER, THE RESULTS CROSSING TO THE LABORATORY INFORMATION SYSTEM (LIS) WERE CORRECT. THERE WERE NO ADVERSE EVENTS REPORTED AS THE RESULTS CROSSED TO THE LIS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425118 ↗
• MalfunctionJan 7, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS A COMPLAINT OF A QUESTIONABLE INSULIN RESULT FOR 1 PATIENT TESTED WITH A COBAS 8000 CORE MODULE. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S REPEATED RESULT WAS "CUT IN HALF" OF THE INITIAL RESULT. SPECIFIC VALUES AND UNITS WERE REQUESTED, BUT NOT PROVIDED. THE LOT NUMBER AND EXPIRATION DATE OF THE INSULIN REAGENT USED WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191676 ↗
• MalfunctionOct 30, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ISE INDIRECT GEN.2 SODIUM RESULT FROM THE COBAS 8000 CORE UNIT. THE INITIAL RESULT WAS 159 MMOL/L AND THE REPEAT RESULT WAS 149 MMOL/L. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER FOUND THE SCREW ON THE SIPPER NOZZLE WAS LOOSE AND TIGHTENED IT. AN ISE CHECK AND QC RESULTS CONFIRMED THE ISSUE WAS RESOLVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8018711 ↗
• MalfunctionSep 19, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE FROM THE COBAS 8000 CORE UNIT. THE INITIAL ELECSYS TSH ASSAY RESULT WAS 0.042 MIU/ML AND THE REPEAT RESULTS WERE 0.044 MIU/ML AND 0.864 MIU/ML. THE INITIAL ELECSYS FT4 II ASSAY RESULT WAS 0.093 NG/DL AND THE REPEAT RESULTS WERE 0.058 NG/DL AND 1.18 NG/DL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SECOND REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TSH REAGENT LOT NUMBER WAS 307192 WITH AN EXPIRATION DATE OF 30-SEP-2018. THE FT4 REAGENT LOT NUMBER WAS 288197. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7888596 ↗
• MalfunctionAug 23, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR VITAMIN D TOTAL ON A COBAS 8000 CORE UNIT. THE DATE OF EVENT IS EITHER (B)(6) 2018. CLARIFICATION ON THE CORRECT DATE HAS BEEN REQUESTED. THE INITIAL VITAMIN D TOTAL RESULT WAS 3.34 NG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 6.77 NG/ML. A NEW SAMPLE WAS OBTAINED AND THE VITAMIN D TOTAL RESULT WAS 16.20 NG/ML. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE VITAMIN D TOTAL REAGENT LOT NUMBER WAS 34167100 WITH AN EXPIRATION DATE OF 30-JUN-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809508 ↗
• MalfunctionAug 13, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR TRSF2 TINA-QUANT TRANSFERRIN VER.2 ON A COBAS 8000 CORE UNIT. THE CUSTOMER STATES THAT THE ISSUE OCCURS INTERMITTENTLY. INITIAL RESULTS FROM AFFECTED SAMPLES WILL BE VERY LOW AND UPON REPEAT, THE RESULT IS NORMAL. THE ISSUE OCCURS WITH 2 TO 3 PATIENT SAMPLES EVERY DAY. THE CUSTOMER PROVIDED DATA FOR TWO PATIENT SAMPLES WITH ERRONEOUS TRSF2 RESULTS. THE ERRONEOUS RESULTS FROM THESE SAMPLES WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH A TRSF2 VALUE OF 2 MG/DL, WHICH REPEATED AS 262 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED WITH A TRSF2 VALUE OF 1 MG/DL, WHICH REPEATED AS 159 MG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE TRSF2 REAGENT LOT NUMBER WAS 33436301, WITH AN EXPIRATION DATE OF 29-FEB-2020. THE CUSTOMER FOUND THE SALINE ON BOARD THE ANALYZER WAS OUT OF STABILITY. CALIBRATION AND CONTROLS WERE OK. THE CUSTOMER MOVED THE ASSAY TO THE OTHER REAGENT DISK OF THE ANALYZER. SINCE THIS ACTION, THE CUSTOMER DID NOT HAVE ANY FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777885 ↗
• MalfunctionAug 1, 2018Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE LOW THYROID RESULTS FOR ONE PATIENT SAMPLE FROM THE COBAS 8000 CORE UNIT. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ELECSYS FT4 II ASSAY WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 0.139 NG/DL AND THE REPEAT RESULT ON (B)(6) 2018 WAS 1.34 NG/DL. ON (B)(6) 2018, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE FT4 RESULT WAS 1.29 NG/DL. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 30320301 WITH AN EXPIRATION DATE OF 30-APR-2019. THE PROVIDED QC DATA DID NOT INDICATE ANY ISSUES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739065 ↗
• MalfunctionJul 25, 2018Patient Data Problem; Patient Data Problem

  THE CUSTOMER STATED THAT THERE IS AN ISSUE WITH THE TRANSMISSION OF PATIENT RESULTS FROM THE DATA MANAGER OF THE COBAS 8000 CORE UNIT TO THE COBAS INFINITY MIDDLEWARE SYSTEM. RESULTS FROM TESTS THAT HAVE BEEN REPEATED SHOW UP IN THE COBAS INFINITY SYSTEM IN REVERSE ORDER. THE REPEAT RESULTS SHOW A TIME STAMP THAT IS PRIOR TO THE FIRST RUN RESULTS. THE ISSUE HAS BEEN DETECTED AT LEAST THREE TIMES. FOR EXAMPLE, ONE SAMPLE TESTED ON A COBAS 8000 ISE MODULE LINKED TO THE COBAS 8000 CORE UNIT HAD AN ISE INDIRECT NA FOR GEN.2 (SODIUM) RESULT THAT INITIALLY RESULTED AS 1032.4 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND RESULTED WITH A VALUE OF 142.6 MMOL/L. IN THE WORKPLACE/SERVICE/SYSTEM AREA OF THE DATA MANAGER SOFTWARE, THE TIME STAMP OF EACH RESULT IS IN THE INCORRECT ORDER. HOWEVER, IN THE WORKPLACE/ROUTINE AREA OF THE DATA MANAGER SOFTWARE, THE TIME AND DATE OF THE RESULTS ARE DISPLAYED CORRECTLY. IN THE COBAS INFINITY SYSTEM, THE FINAL RESULT IS RECEIVED BEFORE THE FIRST RESULT IS RECEIVED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. INVESTIGATIONS OF THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718896 ↗
• MalfunctionJul 19, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CEA ASSAY (CEA) ON A COBAS 8000 CORE UNIT. THE INITIAL CEA RESULT WAS 221.30 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018 A NEW SAMPLE WAS OBTAINED AND THE CEA RESULT WAS 1.56 NG/ML. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 1.56 NG/ML. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CEA REAGENT LOT NUMBER WAS 28657406. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER STATED THE INITIAL SAMPLE WAS LIPEMIC. THE CUSTOMER IS WONDERING IF THIS AFFECTED THE INITIAL HIGH RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703627 ↗
• MalfunctionJul 16, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS 8000 CORE UNIT. INSULIN RESULTS WERE OBTAINED FROM A FASTING SAMPLE, A SAMPLE 1 HOUR AFTER THE FASTING SAMPLE AND A SAMPLE 2 HOURS AFTER THE FASTING SAMPLE. THE INSULIN RESULTS FROM THE FASTING SAMPLE AND THE SAMPLE 2 HOURS LATER WERE DISCREPANT. THE INITIAL INSULIN RESULT FROM AN ALIQUOT OF THE FASTING SAMPLE WAS 0.523 (UNIT OF MEASURE NOT PROVIDED). THIS SAMPLE WAS REPEATED AND THE RESULT WAS 6.93. DURING THE PROCESSING OF THIS SAMPLE, A PROCELL/CLEANCELL SHORT ALARM WAS DISPLAYED. IT WAS DISCOVERED THAT THERE WAS NO FILTER IN THE SET OF CLEANCELL. THE INITIAL INSULIN RESULT FROM AN ALIQUOT OF THE SAMPLE 2 HOURS LATER WAS 0.560. THIS SAMPLE WAS REPEATED AND THE RESULT WAS 13.57 WITH A DATA FLAG. THE PRIMARY TUBE WAS RUN AND THE RESULT WAS 13.43 WITH A DATA FLAG. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE INSULIN REAGENT LOT NUMBER WAS 269702. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QC WERE WITHIN THE ACCEPTABLE RANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691236 ↗
• MalfunctionJul 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR UREAL UREA/BUN (UREAL/BUN) ON A COBAS 8000 CORE UNIT. THE INITIAL UREAL/BUN RESULT WAS 0.3 MMOL/L. THIS RESULT WAS CONVERTED TO A RESULT OF < 0.5 MMOL/L DUE TO A RULE IN THE CUSTOMER'S MIDDLEWARE AND RELEASED FROM THE LABORATORY WITH NO DATA ALARM OR FLAG. THIS RESULT WAS QUESTIONED AND THE SAMPLE WAS REPEATED WITH A RESULT OF 6.8 MMOL/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE UREAL/BUN REAGENT LOT NUMBER WAS 307009. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QC DATA APPEAR TO BE ACCEPTABLE. THE CUSTOMER WAS NOT HAVING ISSUES WITH ANY OTHER ASSAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682626 ↗