ABL800 FLEX 393-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05700693938004), received between Sep 4, 2017 and Jul 31, 2026 — classified as 4 injuries, 77 malfunctions.

The most frequently reported specific device problem is “High Readings” (19 reports).

2 FDA recall records name this device's identifier, 2 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 16, 2026.

Recalls naming this device

1. May 31, 2024Open, Classified

   Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

   Z-2426-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 18, 2022Open, Classified

   There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

   Z-1321-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096445 ↗
• MalfunctionApr 20, 2026Date/Time-Related Software Problem

  RADIOMETER REFERENCE NUMBER (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED, THAT ON (B)(6) 2026, DURING A ROUTINE VISIT, THE ABL800 FLEX ANALYSER (SERIAL NUMBER (B)(6)) WAS RESTART. UPON REBOOT, THE DATE HAS BEEN REVERTED BACK TO (B)(6) 2007. THE TIME DISCREPANCY WAS NOTICED AND CAUSED PATIENT RESULTS TRANSMISSION TO FAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924836 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, AT 19:20, A BLOOD GAS ANALYSIS ON THE BLOOD GAS ANALYZER ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6)) WAS COMPLETED FOR THE PEDIATRIC PATIENT. THE REPORTED RESULTS SHOWED POTASSIUM (K) OF 2.5 MMOL/L AND SODIUM (NA) OF 117 MMOL/L. THE PATIENT WAS IMMEDIATELY ASSESSED AND SHOWED NO SIGNS OF CARDIAC ARRHYTHMIA, SEIZURES, OR OTHER ABNORMAL MANIFESTATIONS. COMPARED WITH THE BLOOD GAS RESULTS AT 06:35 THE SAME MORNING (K 3.4 MMOL/L, NA 132 MMOL/L), THE VALUES DIFFERED SIGNIFICANTLY. AN URGENT REPEAT BIOCHEMICAL ELECTROLYTE TEST WAS ORDERED IMMEDIATELY. IN THE MEANTIME, LOW-DOSE HYPERTONIC SODIUM AND POTASSIUM CITRATE SUPPLEMENTATION WERE INITIATED. AT 20:39, THE BIOCHEMICAL ELECTROLYTE RESULTS WERE REPORTED AS K 3.9 MMOL/L AND NA 134 MMOL/L, AND HYPERTONIC SODIUM AND POTASSIUM CITRATE SUPPLEMENTATION WERE IMMEDIATELY DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907803 ↗
• MalfunctionApr 9, 2026Unable to Obtain Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED SPORADICALLY ABORTED MEASUREMENTS ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6). RADIOMETER FIELD SERVICE ENGINEER HAD CHECKED THE DATA LOGS AND ACTIVITY LOGS OF THE ANALYZER AND COULD NOT FIND THE INFORMATION REGARDING THE ABORTED MEASUREMENTS. 10 TEST MEASUREMENTS WERE CONDUCTED WITHOUT ISSUE. SEVERAL MAINTENANCE AND SERVICE WERE CONDUCTED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829483 ↗
• MalfunctionMar 31, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 SEVERAL MEASUREMENTS HAD UNEXPLAINED DISCREPANCIES IN THE SODIUM VALUES ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6)). TWO MEASUREMENTS WERE PROVIDED BY THE CUSTOMER: 143 MMOL/L AND 150 MMOL/L (DISCREPANT). A SECOND SET OF MEASUREMENTS WAS PROVIDED. THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 4:24 P.M., WITH A VALUE OF 144 MMOL/L, SHOULD REPRESENT THE ACTUAL VALUE COMPARED TO THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 8:42 P.M. WITH NA = 155 MMOL/L (DISCREPANT).

  Patient problems: Insufficient Information

  MAUDE report 24740711 ↗
• MalfunctionMar 18, 2026High Readings

  RADIOMETER REFERENCE NUMBER (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED DIFFERENT RESULTS IN MEASURING CHLORIDES BETWEEN ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6)) AND BECKMAN COULTER AU. THE COMPARISON RESULTS PROVIDED INCLUDE 4 DIFFERENT SAMPLES AND ARE CONSIDERABLY HIGHER FOR ABL800 FLEX ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626132 ↗
• MalfunctionFeb 19, 2026High Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED THAT THEIR ABL800 FLEX ANALYZER (SERIAL NUMBER; (B)(6)) MEASURED APPROXIMATELY 20 MMOL TOO HIGH FOR SODIUM (NA) FOR ABOUT AN HOUR FROM 11:51 TO 12:53 ON (B)(6) 2026. A SAMPLE WAS RUN ON THE ANALYZER AT 11:48, BUT IT DID NOT PRODUCE A RESULT, AND OTHER SAMPLES FROM THE SAME TIME ON DIFFERENT ANALYSIS EQUIPMENT ALSO FAILED, AS THEY WERE COAGULATED. AT 12:53, THE ANALYZER RESOLVED THE PROBLEM ON ITS OWN AND MEASURED CORRECTLY AGAIN. THE PATIENT HAS NA RESULTS OF 132 MMOL/L ON THE 16/2-26 AT 10:31 FROM ALINITY INSTRUMENT. ON THE ABL800 FLEX ANALYZER THEY RECEIVED NA RESULTS ON 157 MMOL/L 16/2-26 AT 12:00 AND 153 MMOL/L 16/2-26 AT 12:27 THEY HAVE CHECKED IF THERE WAS SALINE WATER RUNNING BUT THAT WAS APPARENTLY NOT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387691 ↗
• MalfunctionFeb 16, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 SEVERAL MEASUREMENTS HAD UNEXPLAINED DISCREPANCIES IN THE SODIUM VALUES ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6). TWO MEASUREMENTS WERE PROVIDED BY THE CUSTOMER: 143 MMOL/L AND 150 MMOL/L (DISCREPANT). A SECOND SET OF MEASUREMENTS WAS PROVIDED. THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 4:24 P.M., WITH A VALUE OF 144 MMOL/L, SHOULD REPRESENT THE ACTUAL VALUE COMPARED TO THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 8:42 P.M. WITH NA = 155 MMOL/L (DISCREPANT).

  Patient problems: Insufficient Information

  MAUDE report 24342774 ↗
• MalfunctionFeb 4, 2026Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, THE RADIOMETER BLOOD GAS ANALYZER ABL800 FLEX (SERIAL NUMBER (B)(6)) MEASURED FALSELY LOW LACTATE (CLAC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256062 ↗
• MalfunctionNov 4, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER COMPLAINS ABOUT ABL800 FLEX ANALYZER (SERIAL NO. (B)(6) BRIEFLY SHOWED THE BASIC INPUT/OUTPUT SYSTEM (BIOS) INFO AND THEN GAVE BLACK SCREEN DESPITE REPLACEMENT OF CENTRAL PROCESSING UNIT (CPU) UNIT. NO ADVERSE EVENT OR SERIOUS INJURY WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462308 ↗
• MalfunctionOct 22, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER COMPLAINS ABOUT A WHITE SCREEN DURING SAMPLE MEASUREMENT BY USING ABL800 (SERIAL NUMBER (B)(6) FLEXQ MODULE AND ABORTION OF SAMPLE. AN OPERATOR PLACED A SAMPLE INTO FLEXQ MODULE AND LOGGED OFF. DURING SAMPLE MEASUREMENT OF ABOVE-MENTIONED SAMPLE ANOTHER OPERATOR PUT A FURTHER SAMPLE INTO FLEXQ MODULE FOLLOWED BY ENTRY OF PATIENT DATA. AFTER ENTRY OF PATIENT DATA, THE ANALYZER SCREEN TURNS WHITE, BUT ANALYZER UNIT (AU) CONTINUED WORKING. AFTER COMPLETION OF AU ACTIVITIES, THE OPERATOR RESTARTED THE ANALYZER. THE RUNNING MEASUREMENT WAS ABORTED BUT THE ANALYZER WORKED WITHOUT PROBLEMS AND AS INTENDED AFTER RESTART. NO ADVERSE EVENT OR SERIOUS INJURY WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356881 ↗
• MalfunctionOct 15, 2025Incorrect Measurement; Incorrect Measurement

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE ABL800 FLEX ANALYZER REPORTED FALSELY HIGH SODIUM (NA) VALUES AND FALSELY LOW CHLORIDE (CL) VALUES, LEADING TO INACCURATELY LOW ANION GAP READINGS. THE RECORDED ANION GAP VALUES RANGED FROM 0.2 TO 2.9 MMOL/L, WHEREAS THE EXPECTED RANGE WAS 10 TO 16 MMOL/L. THIS ISSUE OCCURRED BETWEEN (B)(6) 2025. IT WAS REPORTED TO HAVE RESULTED IN INAPPROPRIATE TREATMENT, BUT NO ADVERSE EVENTS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288150 ↗
• MalfunctionOct 15, 2025Incorrect Measurement; Incorrect Measurement

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE ABL800 FLEX ANALYZER REPORTED FALSELY HIGH SODIUM (NA) VALUES AND FALSELY LOW CHLORIDE (CL) VALUES, LEADING TO INACCURATELY LOW ANION GAP READINGS. THE RECORDED ANION GAP VALUES RANGED FROM 0.2 TO 2.9 MMOL/L, WHEREAS THE EXPECTED RANGE WAS 10 TO 16 MMOL/L. THIS ISSUE OCCURRED BETWEEN (B)(6) AND (B)(6) 2025. IT WAS REPORTED TO HAVE RESULTED IN INAPPROPRIATE TREATMENT, BUT NO ADVERSE EVENTS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288080 ↗
• MalfunctionOct 15, 2025Incorrect Measurement; Incorrect Measurement

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE ABL800 FLEX ANALYZER REPORTED FALSELY HIGH SODIUM (NA) VALUES AND FALSELY LOW CHLORIDE (CL) VALUES, LEADING TO INACCURATELY LOW ANION GAP READINGS. THE RECORDED ANION GAP VALUES RANGED FROM 0.2 TO 2.9 MMOL/L, WHEREAS THE EXPECTED RANGE WAS 10 TO 16 MMOL/L. THIS ISSUE OCCURRED BETWEEN (B)(6) 2025. IT WAS REPORTED TO HAVE RESULTED IN INAPPROPRIATE TREATMENT, BUT NO ADVERSE EVENTS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288036 ↗
• MalfunctionAug 1, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4) ACCORDING TO THE COMPLAINT UNPLAUSIBLE PH VALUES WERE MEASURED ON (B)(6) 2025 AT 13:27 AND 13:59; THE ABL800 FLEX PLUS ANALYZER (SERIAL NO; (B)(6) WAS DISPLAYING A GREEN STATUS AT THIS TIME. COMPARATIVE MEASUREMENTS WERE PERFORMED ON 3 ABL800 DEVICES USING 2 PATIENTS FROM DIFFERENT SAFE PICO A SYRINGES (LOT DX17), WITH THE PH VALUE ON THE FAULTY DEVICE BEING APPROX. 0.2 TOO LOW. OPERATING MATERIALS USED: CAL 1 LOT CZ03, CAL 2 LOT CZ02, RINSING SOLUTION LOT DZ65, CLEANING SOLUTION CY02, GAS 1 Y29B68, GAS 2 Y17G82, REF. MEMBRANE LOT R3594. SAMPLE/PATIENT ID (B)(6), 13:37, (B)(6) 2025, PH 7,036 (DISCREPANT), SAMPLE/PATIENT ID (B)(6), 13:44, (B)(6) 2025, PH 7,202 (COMPARISON), SAMPLE/PATIENT ID (B)(6), 13:52,(B)(6) 2025, PH 7,207 (COMPARISON). NO ONE WAS INJURED. THE ABL800 FLEX PLUS ANALYZER IS RUNNING FINE AFTER ELECTRODE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685435 ↗
• MalfunctionJul 22, 2025Low Readings; Low Readings

  ACCORDING TO THE COMPLAINT, TWO GLU RESULTS FROM IDENTICAL SAMPLE MEASURED BY TWO ABL800S ARE DIFFERENT COMPLETELY. THE RESULT FROM THE FIRST ANALYZER (SERIAL NUMBER 754R1522N001) IS 18.7MMOL/L, AND THE OTHER IS >60MMOL/L. A COMPARISON RESULT ON A SIEMENS ANALYZER GAVE RESULT OF 53.64MMOL/L. BASED ON THE COMPARISON RESULT AND PATINET CONDITION, THE RESULT OF 18.7MMOL/L IS REPORTED AS FALSE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564079 ↗
• MalfunctionJul 14, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE (B)(4). ON (B)(6) 2024, THE ANALYZER WAS CHANGED FROM ABL 835 TO ABL 825. THE UNITS OF MEASURE IN AQURE FOR THE ANALYZER WERE INCORRECT (MMOL) AND THEREFORE CORRECTED TO G/DL. (B)(6) 2025 - (B)(6) 2025: THB MEASUREMENT VALUES IN LIS WERE LOWER THAN IN THE ANALYZER. BASED ON THIS UNDERSTANDING: THE ANALYZER TRANSMITS TO AQURE. AQURE TRANSMITS TO LIS. - THE UNITS PROBLEM WAS BETWEEN AQURE AND LIS. - THE CAUSE IS THAT (B)(6) 2024, AFTER CHANGING THE ANALYZER TYPE, AQURE UNITS WERE CHANGED BUT IT WAS MISSED TO ALSO CHANGE THE AQURE MIDDLEWARE UNITS, HENCE THE ROOT CAUSE IS A HUMAN ERROR IN THE CONFIGURATION OF AQURE MIDDLEWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492844 ↗
• MalfunctionJun 20, 2025Computer Software Problem; Loss of Data; Computer Software Problem; Loss of Data

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, OUR RADIOMETER SALES REPRESENTATIVE (RKK) REPORTED FROM THE CUSTOMER ABOUT THIS ON (B)(6) 2025 WHEN HE VISITED AT THE CUSTOMER SITE BUT THE PROBLEM SEEMED HAPPENED ON (B)(6) 2025. THE CAPILLARY MEASUREMENT DATA LOSS FROM THE ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THE ANALYZER BEHAVIOR WAS AS BELOW. 1. READ THE BARCODE FOR THE PATIENT SAMPLE. 2. RAISED THE FLAPPER FOR THE CAPILLARY. 3 STARTED MEASUREMENTS BUT A CALIBRATION WAS STARTED AT SAME TIME. AS RESULT SAMPLE WAS ASPIRATED BUT THE RESULT DIDN'T APPEAR ALSO ONLY THE CALIBRATION DATA WAS RECODED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296007 ↗
• MalfunctionJun 19, 2025Output Problem; Output Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED DURING MONTHLY ANALYSIS OF PATIENT SAMPLES FOR QUALITY CONTROL, THAT NA+ AND CA2+ WERE FALSELY LOW COMPARED TO THE LABORATORY'S INSTRUMENT. THIS OCCURRED ON (B)(6) 2025. ON (B)(6) 2025, THE CUSTOMER BEGAN TROUBLESHOOTING THIS BY CLEANING THE SAMPLE PATH AND REPLACING THE MEMBRANES. CALIBRATIONS AND CONTROLS WERE OKAY, BUT THE DIFFERENCE REMAINED. ON (B)(6) 2025, THE CUSTOMER TRIED REPLACING THE REFERENCE ELECTRODE AND A NEW COMPARISON WAS PERFORMED BUT THE ERROR REMAINED. BELOW ARE THE DISCREPANT AND COMPARISON MEASUREMENTS ALL FROM (B)(6) 2025: NA+ 142MMOL/L (COMPARISON). CA2+ 1,12MMOL/L (COMPARISON). NA+ 134 MMOL/L (DISCREPANT). CA2+ 0,98MMOL/L (DISCREPANT). INFORMATION PROVIDED ON 12JUN2025: "THE DEVIATING TEST RESULT HAS RESULTED IN AN EXTENSION OF THE INTENSIVE CARE PERIOD FOR ONE PATIENT, AS THE CHANGE IN THE ANALYZED SAMPLES LED TO THE TREATMENT BEING ADJUSTED WHEN TRYING TO CORRECT FOR THE CHANGED VALUES. TREATMENT WAS ADJUSTED DUE TO THE INCORRECT VALUES, WHICH LED TO EXTENDED INTENSIVE CARE FOR ONE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289043 ↗
• MalfunctionJun 10, 2025Missing Test Results; Missing Test Results

  ACCORDING TO THE COMPLAINT (B)(4), ON 2025-05-07 AND 2025-05-14, THE CUSTOMER WAS UNABLE TO MEASURE PO2 FOR A PATIENT'S SAMPLE ON THEIR ABL800 FLEX (SERIAL NUMBER: (B)(6). THIS PATIENT IS ON DIALYSIS. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175631 ↗
• MalfunctionMay 20, 2025Electrical /Electronic Property Problem; Output Problem; Patient Data Problem; Electrical /Electronic Property Problem; Output Problem; Patient Data Problem

  ACCORDING TO THE COMPLAINT, CUSTOMER REPORTED, THAT BARCODE PATIENT ID IS MISINTERPRETED BY ABL800 FLEX (SERIAL NUMBER: (B)(6)). A 10-DIGIT PATIENT ID IS SCANNED (CPR#) BUT THE LAST 2 DIGITS ARE MISREAD (02 INSTEAD OF 10). UNFORTUNATELY, THIS PATIENT ID BELONGS TO ANOTHER PERSON IN THE SAME REGION. IT HAPPENED ON THESE SAMPLES: (B)(6) 2025 KL. 02:12. (B)(6) 2025 KL. 07:42. (B)(6) 2025 KL. 19:13. (B)(6) 2025 KL. 07:29. THE BARCODE FORMAT USED WERE CODE128.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050257 ↗
• MalfunctionMar 13, 2025High Readings; High Readings

  ACCORDING TO THE COMPLAINT, ON (B)(6)N 2025 SAMPLES WERE MEASURED ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6) AFTER A RINSE ERROR, AND THE FOLLOWING RESULTS WERE PROVIDED: NA: 268MMOL/L VS 144 MMOL/L (COMPARISON) K : 9.8MMOL/L VS 6.1MMOL/L (COMPARISON) CL : 115MMOL/L VS 111MMOL/L (COMPARISON) CA : 3.21MMOL/L VS 1.22MMOL/L (COMPARISON) HENCE, THE CUSTOMER HAD REPORTED THE ELECTROLYTES RESULTS FROM THE ABL800 FLEX AS FALSE HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593064 ↗
• MalfunctionFeb 13, 2025Computer Software Problem; Computer Software Problem

  ACCORDING TO THE COMPLAINT THE INTENSIVE CARE UNIT HAS CREATED A PHH (POTENTIAL HEALTH HAZARD) ON SAMPLE 4152 ANALYZED ON A ABL800 FLEX ANALYZER (SERIAL NO; (B)(6)) THE (B)(6)2025 AT 8:34. THEY HAVE REGISTERED THE SAMPLE IN FLEXLINK ON PC AS A VENOUS SAMPLE, BUT WHEN SAMPLING THE SAMPLE ON THE ABL800 FLEX ANALYZER, IT IS AUTOMATICALLY REGISTERED AS AN ARTERIAL SAMPLE, AND THIS HAS BEEN TRANSMITTED TO LIS SYSTEM, AND PATIENT JOURNAL. IN AQURE THE RESULTS ARE WITH SAMPLE TYPE VENØS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373515 ↗
• MalfunctionFeb 13, 2025Low Readings; Low Readings

  ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED NOT RELIABLE RESULTS ON PH, CA AND K. HOWEVER, ONLY THE BELOW MEASUREMENTS HAVE BEEN PROVIDED FOR PH AND SBE: (B)(6) 2025, 04:20 PH 6.997 (DISCREPANT), (B)(6) 2025, 05:17 PH 7.027 (DISCREPANT), (B)(6) 2025, 05:52 PH 7.065 (DISCREPANT), (B)(6) 2025, 06:20 PH 7.360 (COMPARISON MEASUREMENT). (B)(6) 2025, 04:20 SBE -19.9MMOL/L (DISCREPANT), (B)(6) 2025, 05:17 SBE -19.5MMOL/L (DISCREPANT), (B)(6) 2025, 05:52 SBE -17.8MMOL/L (DISCREPANT), (B)(6) 2025, 06:20 SBE -3.3MMOL/L (COMPARISON MEASUREMENT). ACCORDING TO THE CUSTOMER, THE ISSUES FOR CA AND K ARE FIXED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372381 ↗
• MalfunctionDec 5, 2024High Readings; High Readings

  ACCORDING TO COMPLAINT, DEVIATING NA+ RESULTS WERE DETECTED BY CUSTOMER ON PATIENT RESULTS IN RELATION TO THE PATIENTS' PREVIOUS RESULTS. THIS DEVIATION ORIGINATES FROM TWO OCCASIONS WITH DEVIANT NA+ RESULTS ON THE ABL800 FLEX ANALYZER (SERIAL NUMBER: (B)(6)). ON BOTH OCCASIONS, CALIBRATIONS AND QC WERE APPROVED. PATIENT RESULTS WERE CHECKED AGAINST THE CENTRAL LABORATORY. OCCASION 1: TIME (B)(6) 2024 17:56 PATIENT SAMPLES WERE ANALYZED AND A NA+ RESULT OF 155.6 MMOL/L WAS OBTAINED. THE USER DID NOT TRUST THIS BECAUSE THE PATIENT FOUR HOURS EARLIER HAD 143 MMOL/L. A VENOUS SAMPLE WAS THEN TAKEN IN A VACCUTAINER WHICH WAS SENT TO THE LABORATORY WHERE A NA+ RESULT OF 141 MMOL/L WAS OBTAINED. AFTER THIS, A 2-POINT CALIBRATION WAS PERFORMED WHICH WAS NOT APPROVED FOR NA, CA AND CL. OCCASION 2: TIME (B)(6) 2024 07:58 A NEW COMPARISON WAS PERFORMED BETWEEN THE ABL AND THE LABORATORY. ON THIS OCCASION THE ABL INDICATED A NA+ OF 160 MMOL/L WHILE THE LABORATORY REPORTED A NA+ OF 147 MMOL/L. AT THE TIME OF ANALYSIS, THE INSTRUMENT WAS APPROVED FOR CALIBRATIONS AND QC. ON THE 19TH, ELECTRODES FOR NA+ AND REF WERE CHANGED AS WELL AS THEIR MEMBRANES AT THE REQUEST OF SERVICE TECHNICIANS. HOWEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851954 ↗