cobas b 221 <6> system 3337154001Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04015630018345), received between Jul 20, 2018 and Mar 30, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 reports).

1 FDA recall record name this device's identifier.

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. Feb 22, 2018Class IITerminated

   The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

   Z-1612-2018 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT PO2, PCO2, CHCO3, BE, AND PH RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS B 221 <6> SYSTEM. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON (B)(6) 2026, RESULTING IN THE FOLLOWING VALUES: PO2 = 159.3 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 99.8 MMHG FOR THE REPEAT VALUE PCO2 = 16.1 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 30.2 MMHG WITH A DATA FLAG FOR THE REPEAT VALUE. CHCO3 = 12.9 MMOL/L FOR THE FIRST VALUE AND 20.6 MMOL/L FOR THE REPEAT VALUE . BE = - 6.6 MMOL/L FOR THE FIRST VALUE AND - 2.1 MMOL/L FOR THE REPEAT VALUE. PH = 7.522 WITH A DATA FLAG FOR THE FIRST VALUE AND 7.452 WITH A DATA FLAG FOR THE REPEAT VALUE. TESTING FOR THE SAMPLE WAS REPEATED ON (B)(6) 2026 WITH A SHORTER DELAY BETWEEN FIRST AND REPEAT MEASUREMENTS. THE FOLLOWING VALUES WERE OBTAINED: PO2 = 162.1 MMHG WITH A DATA FLAG FOR THE FIRST VALUE AND 156.4 MMHG WITH A DATA FLAG FOR THE REPEAT VALUE. PCO2 = 39.0 MMHG FOR THE FIRST VALUE AND 38.8 MMHG FOR THE REPEAT VALUE. CHCO3 = 19.3 MMOL/L FOR THE FIRST VALUE AND 19.0 MMOL/L FOR THE REPEAT VALUE . BE = - 6.2 MMOL/L FOR THE FIRST VALUE AND - 6.7 MMOL/L FOR THE REPEAT VALUE. PH = 7.313 WITH A DATA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728310 ↗
• MalfunctionDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE POTASSIUM ELECTRODE RESULT FROM THE COBAS B 221 <6> SYSTEM, THE UNIT OF MEASUREMENT WAS REQUESTED BUT NOT PROVIDED. PATIENT 1'S INITIAL RESULT FROM THE B221 SYSTEM WAS 7, AND THE RESULT FROM AN UNSPECIFIED CHEMISTRY ANALYZER WAS 3.5. PATIENT 2'S INITIAL RESULT FROM THE B221 SYSTEM WAS 8, AND THE RESULT FROM AN UNSPECIFIED CHEMISTRY ANALYZER WAS 3.3. ADDITIONAL RESULTS WERE PROVIDED. IT IS UNCLEAR IF THESE ARE ADDITIONAL PATIENT RESULTS OR QC RESULTS. CLARIFICATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE INITIAL RESULT FROM THE B221 SYSTEM WAS 6.13, AND THE REPEAT RESULT ON ANOTHER COBAS B221 SYSTEM WAS 3.27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778447 ↗
• MalfunctionOct 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES ON A COBAS B 221 AND SYSTEM. IT WAS ALLEGED THAT THE CUSTOMER EXPERIENCED VERY HIGH BLOOD GLUCOSE LEVELS WITH THIS INSTRUMENT COMPARED TO OTHER DEVICES. IT WAS REPORTED THAT SAMPLES WITH BLOOD GLUCOSE LEVELS ABOVE 100 MG/DL HAD A DIFFERENCE OF 50 MG/DL WHEN REPEATED, AND SAMPLES WITH BLOOD GLUCOSE LEVELS ABOVE 200 MG/DL HAD A DIFFERENCE OF 100 MG/DL OR MORE WHEN REPEATED. TWO EXAMPLES WERE PROVIDED. SAMPLE 1: THE INITIAL RESULT WAS 354 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER COBAS B 221 DEVICE, AND THE RESULT WAS APPROXIMATELY 254 MG/DL (100 MG/DL LESS). THE SAMPLE WAS REPEATED USING "A CHEMISTRY DEVICE," AND THE RESULT WAS "NEARLY THE SAME". THE TYPE OF DEVICE AND THE NUMERICAL RESULT WERE NOT PROVIDED. SAMPLE 2: THE INITIAL RESULT WAS 41.8 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER COBAS B 221 DEVICE, AND THE RESULTS WERE 145 MG/DL AND 146 MG/DL. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS WERE QUESTIONED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416585 ↗
• MalfunctionAug 27, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HEMOGLOBIN AND HEMATOCRIT RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS B 221 <6> SYSTEM. THE INITIAL HEMOGLOBIN RESULT FROM THE ANALYZER WAS 4.31 G/DL (43.1 G/L). THE REPEAT RESULT FROM ANOTHER LABORATORY DEVICE WAS 7.91 G/DL (79 G/L). THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 12.7%. THE REPEAT RESULT FROM ANOTHER LABORATORY DEVICE WAS 0.23 L/L (23%). THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902309 ↗
• MalfunctionAug 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HEMOGLOBIN (THB) AND HEMATOCRIT RESULTS FROM FOURTEEN (14) PATIENT SAMPLES TESTED ON THE COBAS B 221 <6> SYSTEM. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES: PATIENT SAMPLE 1 ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 5.29 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 17.2%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 7.7 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 23.7%. PATIENT SAMPLE 2: ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 4.83 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 28.3%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 6.1 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 17.7%. PATIENT SAMPLE 3: ON (B)(6) 2025: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 18.6% (THE THB RESULT WAS 3.16 G/DL). THE REPEAT HEMATOCRIT RESULT FROM THE FLOW CYTOMETER WAS 10% (THE THB RESULT WAS 3.2 G/DL). PATIENT SAMPLE 4: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 20.7% (THE THB RESULT WAS 5.14 G/DL). THE REPEAT HEMATOCRIT RESULT FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873230 ↗
• MalfunctionAug 19, 2025Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM ELECTRODE (NA) AND CHLORIDE ELECTRODE (CL) ON A COBAS C 303 ANALYTICAL UNIT AND A COBAS B 221 <6> SYSTEM. THIS MEDWATCH WILL COVER THE RESULTS FROM THE B221 SYSTEM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE RESULTS FROM THE C303 ANALYZER. FOR NA: THE AVL SYSTEM RESULT WAS 134 MMOL/L. THE C303 ANALYZER RESULT WAS 134 MMOL/L. THE B221 RESULT WAS 137.5 MMOL/L. THE HIBRID SYSTEM RESULT WAS 143 MMOL/L. THE C303 ANALYZER RESULT AND THE HIBRID SYSTEM RESULTS ARE DISCREPANT. FOR CL: THE C303 ANALYZER RESULT WAS 105 MMOL/L. THE B221 RESULT WAS 103.7 MMOL/L. THE HIBRID SYSTEM RESULT WAS 115 MMOL/L. THE B221 SYSTEM AND THE HIBRID SYSTEM RESULTS ARE DISCREPANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839419 ↗
• MalfunctionAug 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM RESULTS FROM THE COBAS B 221 <6> SYSTEM. AT 6:25 AM, THE RESULT WAS 6.93 MMOL/L. AT 9:03 AM, THE RESULT FROM AN UNKNOWN DEVICE WAS 4.3 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686690 ↗
• MalfunctionJun 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 NEONATE PATIENT SAMPLE TESTED FOR BILIRUBIN ON A COBAS B 221 6 SYSTEM. THE RESULT FROM THE B221 SYSTEM WAS 28.8 MG/DL. AS THIS RESULT WAS HIGH, THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AND TESTED IT ON A COBAS C311 INSTRUMENT WITH A RESULT OF 15.91 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142169 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR ONE PATIENT SAMPLE BETWEEN A COBAS B 221 6 SYSTEM AND A GLUCOMETER. THE INITIAL RESULT WAS 10 MG/DL. THE REPEATED RESULT, TESTED AT THE PHYSICIAN'S OFFICE WITH A GLUCOMETER, WAS 70 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924761 ↗
• MalfunctionSep 13, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE K ELECTRODE ON A COBAS B 221 6 SYSTEM. THE CUSTOMER STATED THAT THE K ELECTRODE AND REFERENCE ELECTRODE WERE CHANGED. CALIBRATION AND CONTROLS WERE WITHIN RANGE. THE CUSTOMER THEN NOTICED HIGH K RESULTS. THE WHOLE BLOOD SAMPLES OF THE PATIENTS ARE INITIALLY TESTED. THESE SAMPLES ARE CENTRIFUGED AND THE PLASMA IS THEN TESTED. FOR THE FIRST PATIENT SAMPLE, THE WHOLE BLOOD RESULTED IN A K VALUE OF 6.94 MMOL/L. THE PLASMA RESULTED IN A K VALUE OF 4.54 MMOL/L. THE PLASMA WAS ALSO TESTED ON A SECOND COBAS B 221 SYSTEM, RESULTING IN A K VALUE OF 4.46 MMOL/L. FOR THE SECOND PATIENT SAMPLE, THE WHOLE BLOOD RESULTED IN A K VALUE OF 5.57 MMOL/L. THE PLASMA RESULTED IN A K VALUE OF 3.42 MMOL/L. THE PLASMA WAS ALSO TESTED ON A SECOND COBAS B 221 SYSTEM, RESULTING IN A K VALUE OF 3.41 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217112 ↗
• MalfunctionAug 21, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS WHOLE BLOOD SAMPLES TESTED FOR POTASSIUM (K) ON A COBAS B221 6 ROCHE OMNI S6 SYSTEM COMPARED TO A DIFFERENT COBAS B221 6 ROCHE OMNI S6 SYSTEM. SAMPLE (B)(6) (PATIENT (B)(6)): INITIAL RESULT: 9.21 MMOL/L (TESTED FROM ARTERIAL BLOOD). REPEAT RESULT: 2.96 MMOL/L (TESTED FROM ARTERIAL BLOOD ON ANOTHER COBAS B221 6 ROCHE OMNI S6 SYSTEM). SAMPLE (B)(6) (PATIENT (B)(6)): INITIAL RESULT: 8.70 MMOL/L (TESTED FROM VENOUS BLOOD). REPEAT RESULT: 4.01 MMOL/L (TESTED FROM ARTERIAL BLOOD ON ANOTHER COBAS B221 6 ROCHE OMNI S6 SYSTEM). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES ON ANOTHER COBAS B221 6 ROCHE OMNI S6 SYSTEM WITHIN A FEW MINUTES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT AS THEY MATCHED THE PATIENTS' HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011817 ↗
• MalfunctionJul 12, 2024Unable to Obtain Readings; Non Reproducible Results; Unable to Obtain Readings; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PO2 AND GLUCOSE RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS B 221 6 ROCHE OMNI S6 SYSTEM. ON (B)(6) 2024: PATIENT SAMPLE 1 AT 6:27 AM, THE INITIAL PO2 RESULT WAS 96.3 MMHG. AT 6:30 AM, THE REPEAT RESULT WAS 124.0 MMHG. AT 6:27 AM, THE INITIAL GLUCOSE RESULT WAS 25.0 MG/DL. AT 6:30 AM, THE REPEAT RESULT WAS 148.0 MG/DL. PATIENT SAMPLE 2 AT 6:35 AM, THE INITIAL PO2 RESULT WAS 99.2 MMHG. AT 6:38 AM, THE REPEAT RESULT WAS 112.1 MMHG. AT 6:35 AM, THE INITIAL GLUCOSE RESULT WAS 17.5 MG/DL (18 MG/DL). AT 6:38 AM, THE REPEAT RESULT WAS 129.0 MG/DL. ON (B)(6) 2024: PATIENT SAMPLE 3 AT 6:13 AM, THE INITIAL GLUCOSE RESULT WAS 44.4 MG/DL. AT 6:19 AM, THE REPEAT RESULT WAS 117.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730847 ↗
• MalfunctionJul 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS B 221 6 SYSTEM. THE INITIAL RESULT WAS 245.9 MG/DL. THE REPEATED RESULT WAS 26.7 MG/DL. THE REPEATED RESULT WAS OBTAINED ON ANOTHER B 221 INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658807 ↗
• MalfunctionMay 16, 2024Computer Software Problem; Program or Algorithm Execution Failure; Computer Software Problem; Program or Algorithm Execution Failure

  THE INITIAL REPORTER STATED THERE WAS A SOFTWARE ISSUE WITH FOUR OF THEIR COBAS B 221 6 SYSTEMS. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE CUSTOMER ALLEGES THAT INTERNAL QUALITY CONTROL LOCKS SET UP FOR THE PO2, CL, GLUCOSE, AND LACTOSE ASSAYS WERE DEACTIVATED. THIS ALLOWS PATIENT MEASUREMENTS TO BE COMPLETED WHILE INTERNAL CONTROLS ARE OUTSIDE OF RANGE. THE CUSTOMER BELIEVES THE ISSUE OCCURRED "A NUMBER OF MONTHS AGO", BUT WAS ONLY NOTED ONCE INTERNAL CONTROLS WERE UNACCEPTABLE. THERE WAS NO ALLEGATION OF DISCREPANT PATIENT RESULTS DUE TO THE ISSUE. A SERIAL NUMBER OF (B)(6) WAS PROVIDED FOR ONE OF THE AFFECTED SYSTEMS. THE SERIAL NUMBERS OF THE OTHER THREE SYSTEMS WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332291 ↗
• MalfunctionApr 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR BILIRUBIN ON A COBAS B 221 6 SYSTEM COMPARED TO A COBAS C 503 ANALYTICAL UNIT. THE RESULT FROM THE C503 ANALYZER WAS 18.6 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT AS IT CORRESPONDED TO THE PATIENT¿S CLINICAL PICTURE. THE RESULT FROM THE B221 ANALYZER WAS 30.7 MG/DL. DUE TO THIS HIGH RESULT, A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE B221 ANALYZER WAS 25.0 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182404 ↗
• MalfunctionApr 8, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR PCO2, PH, AND SODIUM (NA) ON A COBAS B 221 6 SYSTEM COMPARED TO A COMPETITOR SYSTEM. THE PCO2 RESULT FROM THE B221 SYSTEM WAS 76.2 MMHG. THE PCO2 RESULT FROM THE COMPETITOR SYSTEM WAS 52.8 MMHG. THE PH RESULT FROM THE B221 SYSTEM WAS 7.176. THE PH RESULT FROM THE COMPETITOR SYSTEM WAS 7.346. THE NA RESULT FROM THE B221 SYSTEM WAS 133.7 MMOL/L. THE NA RESULT FROM THE COMPETITOR SYSTEM WAS 142 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061509 ↗
• MalfunctionMar 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A COBAS B 221 6 SYSTEM. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR SODIUM (NA+) AND CALCIUM (CA+). PATIENT 1 INITIAL NA+ RESULT WAS 167.2 MMOL/L. THE RESULT FROM A DIFFERENT B 221 SYSTEM WAS 156.3 MMOL/L. PATIENT 2 INITIAL CA+ RESULT WAS 4.06 MG/DL. THE RESULT FROM A DIFFERENT B 221 SYSTEM WAS 4.96 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904160 ↗
• MalfunctionNov 16, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR POTASSIUM ELECTRODE (K+) ON A COBAS B 221 6 SYSTEM. EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES. ON (B)(6) 2023 PATIENT B INITIAL RESULT FROM AN ARTERIAL SAMPLE WAS 10.20 MMOL/L. THE RESULT FROM A VENOUS SAMPLE WAS 3.13 MMOL/L. AS THESE ARE DIFFERENT SAMPLE TYPES, THE RESULTS FOR PATIENT B MAY BE FROM DIFFERENT SAMPLES. ON (B)(6) 2023 PATIENT A INITIAL RESULT FROM A VENOUS SAMPLE ON A DIFFERENT B221 SYSTEM WAS 2.88 MMOL/L. THE RESULT FROM THE B221 SYSTEM IN QUESTION FROM AN UNKNOWN SAMPLE TYPE WAS 4.29 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148728 ↗
• MalfunctionOct 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE K ELECTRODE ON A COBAS B 221 6 SYSTEM. THE SAMPLE RESULTED IN A K VALUE OF 5.380 MMOL/L WHEN TESTED ON THE COBAS B 221 INSTRUMENT. THE SAMPLE WAS REPEATED ON A COBAS 6000 ANALYZER, RESULTING IN A K VALUE OF 3.500 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907194 ↗
• MalfunctionOct 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA, K FOR GEN.2 AND CA CALCIUM RESULTS FROM SAMPLES FROM TWO PATIENTS TESTED ON THE COBAS B 221 6 ROCHE OMNI S6 SYSTEM. SAMPLE 1 ON (B)(6) 2023: THE INITIAL K RESULT AT 11:23 AM WAS AN ERROR MESSAGE. THE FIRST REPEAT K RESULT AT 11:25 AM WAS 10.88 MMOL/L. THE SECOND REPEAT K RESULT AT 11:32 AM WAS 3.90 MMOL/L. THE INITIAL NA RESULT AT 11:23 AM WAS AN ERROR MESSAGE. THE FIRST REPEAT NA RESULT AT 11:25 AM WAS 134.8 MMOL/L. THE SECOND REPEAT NA RESULT AT 11:32 AM WAS 141.4 MMOL/L. THE INITIAL CA RESULT AT 11:23 AM WAS AN ERROR MESSAGE. THE FIRST REPEAT CA RESULT AT 11:25 AM WAS 0.859 MMOL/L. THE SECOND REPEAT CA RESULT AT 11:32 AM WAS 1.192 MMOL/L. SAMPLE 2 ON (B)(6) 2023 AT 11:52 PM, THE INITIAL K RESULT WAS 8.52 MMOL/L. ON (B)(6) 2023 AT 12:00 AM, THE FIRST REPEAT K RESULT WAS AN ERROR MESSAGE. THE SECOND REPEAT K RESULT AT 12:07 AM WAS 4.23 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905943 ↗
• MalfunctionAug 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH POTASSIUM (K) ON A COBAS B221 6 OMNI S6 SYSTEM. ON (B)(6) 2023 THE FOLLOWING RESULTS WERE OBTAINED: SAMPLE 1 (TYPE UNKNOWN) AT 12:57 P.M. RESULTED IN 3.78 MMOL/L. SAMPLE 2 (ARTERIAL) AT 12:59 P.M. RESULTED IN 10.87 MMOL/L. SAMPLE 3: A NEW SAMPLE WAS TAKEN (ARTERIAL) AT 2:22 P.M. AND RESULTED IN 4.23 MMOL/L. SAMPLE 4 AT 2:24 P.M. THE RESULT WAS MORE THAN 20 MMOL/L (ACCOMPANIED WITH A DATA FLAG). SAMPLE 5 AT 3:22 P.M. THE RESULT WAS MORE THAN 20 MMOL/L (ACCOMPANIED WITH A DATA FLAG). SAMPLE 6 (SERUM) WAS TESTED ON A DIFFERENT ANALYZER AT 2:31 P.M. AND RESULTED IN 4.4 MMOL/L. SAMPLE 7: A NEW SAMPLE WAS TAKEN (TYPE UNKNOWN) AT 2:35 P.M. AND RESULTED IN 12.56 MMOL/L. SAMPLE 8: A NEW SAMPLE WAS TAKEN (TYPE UNKNOWN) AT 3:43 P.M. AND RESULTED IN 11.92 MMOL/L. SAMPLE 9 (SERUM) WAS TESTED ON A DIFFERENT B221 ANALYZER AT 5:53 P.M. AND RESULTED IN 3.9 MMOL/L. SAMPLE 10 WAS TESTED ON A DIFFERENT B221 ANALYZER AT 6:26 P.M. AND RESULTED IN 4.0 MMOL/L. SAMPLE 11: THE SAME BLOOD SAMPLE WAS THEN TESTED AT 6:28 P.M. AND RESULTED IN 3.2 MMOL/L. IT IS UNKNOWN AT THIS TIME IF SAMPLES 9 AND 10 WERE REPEAT MEASUREMENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563443 ↗
• MalfunctionJul 14, 2023Corroded; Material Discolored; Melted; Corroded; Material Discolored; Melted

  THERE WAS AN ALLEGATION OF CORRODED PARTS ON A COBAS B221 INSTRUMENT. PICTURES WERE PROVIDED INDICATING SOME PARTS WERE MELTED. THE REPORTER STATED LEAKAGE WAS VISIBLE NEAR A TUBING CONNECTOR ASSOCIATED WITH 2 CARTRIDGES OF THE INSTRUMENT. THERE WERE GREEN DEPOSITS ON THE CONNECTORS OF THE METABOLITE-SENSITIVE SENSOR (MSS) MEASURING CHAMBER AND THE CABLE ACTUATOR. THE MAINBOARD UNIT, THE CO-OXIMETRY (COOX) CUVETTE UNIT AND THE ACTUATOR BOARD SHOWED SIGNS OF MELTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323522 ↗
• MalfunctionJun 20, 2023Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH A COBAS B 221 INSTRUMENT. THE CUSTOMER ALLEGED THAT QC FOR PO2 WAS OUTSIDE OF THE ACCEPTABLE RANGE, HOWEVER, THE QC LOCK FUNCTION DID NOT OPERATE CORRECTLY. THE INSTRUMENT SHOWED A WARNING BUT DID NOT LOCK. THE CUSTOMER ALLEGED ALL PARAMETERS OF THE INSTRUMENT WERE SET TO QC LOCK, HOWEVER, THE MULTIRULES SETTING HAD BEEN CHANGED AND WAS NOT SET TO 2 STANDARD DEVIATIONS (SD). DUE TO THIS CHANGE IN THE SETTINGS, PATIENT RESULTS WERE RELEASED WHEN THEY SHOULD NOT HAVE BEEN AS QC WAS OUTSIDE OF THE ACCEPTABLE RANGE. THE CUSTOMER HAS NOT ALLEGED ANY ISSUES WITH THE PATIENT RESULTS THAT WERE RELEASED. THE CUSTOMER LOST POWER ON (B)(4) 2023 AND QUESTIONS WHETHER THIS WOULD HAVE AFFECTED THE INSTRUMENT QC SETTINGS. THE CUSTOMER HAS CHANGED THE MULTIRULES SETTING BACK TO 2SD AND PERFORMED A CONTROLLED SHUTDOWN TO LOCK THIS SETTING IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165708 ↗
• MalfunctionJun 5, 2023Data Problem; Data Problem

  THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH A COBAS B 221 SYSTEM. AFTER REPLACING THE HARD DRIVE ON THE INSTRUMENT, THE PARAMETERS WERE INCORRECTLY CONFIGURED FROM A SAMPLE TYPE OF "BLOOD" TO THE SAMPLE TYPE OF "AQUEOUS SOLUTION." THE CUSTOMER RECONFIGURED THE PARAMETERS BACK TO THE CORRECT SETTING ("BLOOD" SAMPLE TYPE), PERFORMED A CONTROLLED INSTRUMENT SHUTDOWN, AND REBOOTED THE SYSTEM. AFTER REBOOTING THE SYSTEM, THE SETTINGS REVERTED BACK TO "AQUEOUS SOLUTION" AS THE SAMPLE TYPE INSTEAD OF SAVING THE CORRECT SETTING ("BLOOD" SAMPLE TYPE). THE CUSTOMER ATTEMPTED TO RESET THE INSTRUMENT 2 MORE TIMES BUT THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061051 ↗
• MalfunctionApr 19, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT K FOR GEN.2 RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS B 221 6 ROCHE OMNI S6 SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE MEDICAL PERSONNEL. PATIENT 1: THE INITIAL RESULT FROM THE B 221 WAS 7.07 MMOL/L. THE REPEAT RESULT FROM THE B 221 WAS 4.48 MMOL/L. PATIENT 2: THE INITIAL RESULT FROM THE B 221 WAS 8.96 MMOL/L. THE PATIENT SAMPLE WAS RERUN ON ANOTHER LABORATORY INSTRUMENT AND THE REPEAT RESULT WAS 7.2 MMOL/L. THE ELECTRODE LOT NUMBER IS 21524047. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773018 ↗