cobas b 123 <4> POC system 5122287001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630036950), received between Aug 1, 2018 and Aug 10, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PH, PCO2, PO2, AND GLUCOSE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS B 123 < 4 > POC SYSTEM. THE PATIENT SAMPLE WAS RERUN ON THE COBAS B 123 < 4 > POC SYSTEM AND ON THE COBAS B 221. THE INITIAL RESULT WAS REPORTED TO THE MEDICAL PERSONNEL TREATING THE PATIENT. REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201274 ↗
• MalfunctionOct 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT SODIUM (NA) RESULTS FOR 1 PATIENT TESTED ON A COBAS B 123 SYSTEM COMPARED TO A BECKMAN COULTER ANALYZER. THE NA RESULT FROM THE BECKMAN COULTER ANALYZER AT 1:59 P.M. WAS 162 MMOL/L. A SAMPLE WAS OBTAINED AT 1:59 P.M. FOR THE COBAS B 123 INSTRUMENT AND THE NA RESULT AT 2:09 P.M. WAS 152 MMOL/L. THE CUSTOMER PERFORMED COMPARISON TESTING WITH THE PATIENT SAMPLE FOR TROUBLESHOOTING PURPOSES ON 4 OTHER COBAS B123 INSTRUMENTS: COBAS B 123 #1 AT 2:11 P.M. WAS 156 MMOL/L, COBAS B 123 #2 AT 2:17 P.M. WAS 159 MMOL/L, COBAS B 123 #3 AT 2:31 P.M. WAS 161 MMOL/L, COBAS B 123 #4 AT 2:37 P.M. WAS 161 MMOL/L . THE CUSTOMER IS CONCERNED WITH THE LOWER NA RESULT OF 152 MMOL/L FROM THE B 123 INSTRUMENT IN QUESTION. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. QC AND CALIBRATION WERE ACCEPTABLE. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960588 ↗
• MalfunctionOct 9, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED RESULTS FOR 2 PATIENTS TESTED ON 2 COBAS B 123 INSTRUMENTS LOCATED IN THE NEONATAL UNIT COMPARED TO A SIEMENS 1265 BLOOD GAS ANALYZER. BASED ON THE DATA PROVIDED, THE RESULTS FOR PH, PCO2 AND PO2, NA, BE, SO2, METHB AND CHCO3 WERE DISCREPANT. THIS MEDWATCH WILL COVER PATIENT 2 TESTED ON COBAS B 123 INSTRUMENT SERIAL NUMBER (B)(4) AND B 123 INSTRUMENT SERIAL NUMBER (B)(4). REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON PATIENT 1 TESTED ONLY ON COBAS B 123 INSTRUMENT SERIAL NUMBER (B)(4). PATIENT 1 WAS INITIALLY TESTED AT 6:05 A.M. ON B 123 INSTRUMENT SERIAL NUMBER (B)(4) WITH A PH RESULT OF 7.166, A PCO2 RESULT OF 9.37 KPA AND A PO2 RESULT OF 4.48 KPA. AT 6:19 A.M. A NEW SAMPLE WAS OBTAINED AND TESTED ON B123 INSTRUMENT SERIAL NUMBER (B)(4)WITH A PH RESULT OF 7.151, A PCO2 RESULT OF 10.55 KPA, A PO2 RESULT OF 4.61 KPA, A BE RESULT OF [-] 4.97 MMOL/L, AN SO2 RESULT OF 71.9% AND A METHB RESULT OF 1.2%. PATIENT 1 DID NOT APPEAR TO BE IN RESPIRATORY DISTRESS AS THE RESULTS INDICATED; THE SAMPLE FROM 6:19 A.M. WAS REPEATED ON THE SIEMENS INSTRUMENT WITH A PH RESULT OF 7.298, PCO2 RESULT OF 6.52 KPA, A PO2 RESULT OF 6.32 KPA, A BE RESULT OF [-]

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946344 ↗
• MalfunctionOct 9, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED RESULTS FOR 2 PATIENTS TESTED ON 2 COBAS B 123 INSTRUMENTS LOCATED IN THE NEONATAL UNIT COMPARED TO A SIEMENS 1265 BLOOD GAS ANALYZER. BASED ON THE DATA PROVIDED, THE RESULTS FOR PH, PCO2, PO2, NA, BE, SO2, METHB AND CHCO3 WERE DISCREPANT. THIS MEDWATCH WILL COVER PATIENT 1 TESTED ON COBAS B 123 INSTRUMENT SERIAL NUMBER (B)(4). REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON PATIENT 2 TESTED ON COBAS B 123 INSTRUMENT SERIAL NUMBER (B)(4) AND COBAS B 123 INSTRUMENT (B)(4). PATIENT 1 WAS INITIALLY TESTED AT 6:05 A.M. ON B 123 INSTRUMENT SERIAL NUMBER (B)(4) WITH A PH RESULT OF 7.166, A PCO2 RESULT OF 9.37 KPA AND A PO2 RESULT OF 4.48 KPA. AT 6:19 A.M. A NEW SAMPLE WAS OBTAINED AND TESTED ON B123 INSTRUMENT SERIAL NUMBER (B)(4) WITH A PH RESULT OF 7.151, A PCO2 RESULT OF 10.55 KPA, A PO2 RESULT OF 4.61 KPA, A BE RESULT OF [-] 4.97 MMOL/L, AN SO2 RESULT OF 71.9% AND A METHB RESULT OF 1.2%. PATIENT 1 DID NOT APPEAR TO BE IN RESPIRATORY DISTRESS AS THE RESULTS INDICATED; THE SAMPLE FROM 6:19 A.M. WAS REPEATED ON THE SIEMENS INSTRUMENT WITH A PH RESULT OF 7.298, PCO2 RESULT OF 6.52 KPA, A PO2 RESULT OF 6.32 KPA, A BE RESULT OF [-] 3.7 MMOL/L, AN SO2 RESULT OF 89.2

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946342 ↗
• MalfunctionAug 1, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 5 PATIENTS TESTED FOR SODIUM (NA) ON A COBAS B 123 INSTRUMENT LOCATED IN THE INTENSIVE CARE UNIT OF THE HOSPITAL. THE CUSTOMER PROVIDED DISCREPANT HIGH RESULTS FOR 1 PATIENT. THE NA RESULT FROM A BECKMAN AU5800 LABORATORY ANALYZER WAS 139 MMOL/L AT 9:21 A.M. THE RESULTS FROM THE B 123 INSTRUMENT WERE 138 MMOL/L AT 10:03 A.M., 153 MMOL/L AT 2:49 P.M. AND 142 MMOL/L AT 6:53 P.M. THE CUSTOMER REPLACED THE NA SENSOR CARTRIDGE AT APPROXIMATELY 1:30 P.M. ALL CALIBRATIONS PASSED. THE RESULT OF 153 MMOL/L WAS THOUGHT TO BE TOO HIGH. HOSPITAL STAFF SUSPECTED IT WAS INCORRECT AND DID NOT TAKE ANY ACTION BASED ON IT. ON (B)(6) 2018 THE PATIENT HAD AN NA RESULT FROM THE BECKMAN AU5800 ANALYZER OF 142 MMOL/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE NA SENSOR CARTRIDGE LOT NUMBER WAS 21581791. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND CARRIED OUT A SENSOR SIMULATOR TEST. THE RESULTS SHOWED THE SENSOR WAS OK. THE SYSTEM PASSED ALL CALIBRATIONS AND QC. NO INSTRUMENT ISSUES WERE IDENTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739161 ↗