ABL800 FLEX 393-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05700693938011), received between Jul 10, 2017 and Sep 2, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “High Readings” (14 reports).

1 FDA recall record name this device's identifier, 1 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 18, 2026.

Recalls naming this device

1. May 18, 2022Class IIOpen, 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Low Readings

  Patient problems: Insufficient Information

  MAUDE report 50558285 ↗
• MalfunctionAug 20, 2026Missing Test Results

  Patient problems: Insufficient Information

  MAUDE report 50339048 ↗
• MalfunctionNov 19, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, FIVE PATIENT SAMPLES MEASURED ON THE ABL800 FLEX ANALYZER (SERIAL NO. (B)(6) WERE RECALLED ON 2025-03-18. AT 13:36, THE ANALYZER WAS PLACED IN STOP MODE WITHOUT ANY DOCUMENTED ACTION, REPLACEMENT, OR INDICATION OF THE REASON. -CALIBRATION WAS CONFIRMED AS OK AT 11:34. -CREATININE RESULTS WERE ACCEPTABLE AT 13:22 BUT NOT AT 14:00, WHEN THE FIRST PATIENT SAMPLE SHOWED AN ABNORMALLY LOW CREATININE VALUE. -AT 14:04, ANOTHER SAMPLE WAS ANALYZED, RETURNING "?" FOR ALL PARAMETERS. NO INSTRUMENT ALARM WAS TRIGGERED AFTER THIS EVENT. -AT 14:31, THE EQUALIS CONTROL WAS ANALYZED, YIELDING A RESULT OF 45 MOL/L COMPARED TO THE METHOD GROUP RESULT OF 128 MOL/L. THE DEVIATION WAS SO SIGNIFICANT THAT THE VALUE WAS EXCLUDED FROM STATISTICAL ANALYSIS. THERE WAS NO HARM TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593118 ↗
• MalfunctionSep 3, 2025High Readings; High Readings

  RADIOMETER REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 THE USER EXPERIENCED DISCREPANT MEASUREMENTS ON THE ABL800 FLEX ANALYZER (SERIAL NUMBER: (B)(6)), POSSIBLY DUE TO A CLOT. ON (B)(6) 2025 - 23:53 - CLOT POSSIBLY INTRODUCED INTO ANALYZER. SAMPLE STATUS WAS 'INTERRUPTED.' (NO MESSAGES PRESENT) ON (B)(6) 2025 - 23:56 - SAMPLE ABORTED (0328 NO LEADING AIR SEGMENT IN INLETS LIQUID SENSOR WITHIN TIME FRAME). ON (B)(6) 2025 - 00:29 - SAMPLE ABORTED (0328 NO LEADING AIR SEGMENT IN INLETS LIQUID SENSOR WITHIN TIME FRAME). NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949366 ↗
• MalfunctionJan 6, 2025High Readings; High Readings

  ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT THEY WERE IN THE PROCESS OF INVESTIGATING A SERIOUS POTASSIUM DISCREPANT RESULT REPORTED FROM ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6). ON (B)(6)2024, A POTASSIUM OF 9.5 WAS RESULTED FROM THE ABL800 FLEX ANALYZER. THE PROVIDER CALLED QUESTIONING THE RESULT TO WHICH THE TECHNOLOGIST REPEATED THE SAMPLE ON ABL837-A TO WHICH THE POTASSIUM WAS 3.2. BOTH ANALYZERS HAD SUCCESSFUL QC RUN AT 0700 THAT MORNING. THE ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6) ALSO HAD A SUCCESSFUL 2-POINT CALIBRATION AT 9AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077923 ↗
• MalfunctionNov 22, 2023High Readings; High Readings

  ACCORDING TO THE COMPLAINT, THE CUSTOMER HAS INFORMED THEY HAVE NOTICED INTERMITTENT (THOUGH INCREASING IN FREQUENCY) HIGH SODIUM (NA) RESULTS ON THEIR DEVICE ABL800 FLEX ANALYZER (SERIAL NUMBER: (B)(6)) COMPARED TO MAINFRAME (ABBOTT). NA RESULTS ARE ABOVE REFERENCE RANGE BY APPROX. 10 MMOL/L (REF VALUES FOR NA ARE 136-146 MMOL/L.). NO INCIDENT/ADVERSE EVENT HAS BEEN RECORDED, AND LAB MANAGER HAS TURNED OFF NA REPORTING. THE ISSUE WAS FIRST NOTICED ON 6/7 NOVEMBER 2023. 06NOV2023 140 VS 159 MMOL/L. 06NOV2023 138 VS 150 MMOL/L. CUSTOMER REPORTED THE VALUES 159MMOL/L AND 150 MMOL/L AS FALSE HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191613 ↗
• MalfunctionMay 23, 2023Incorrect Measurement; High Readings; Low Readings; Incorrect Measurement; High Readings; Low Readings

  ACCORDING TO THE COMPLAINT, INCORRECT THB RESULTS WAS MEASURED ON TWO BLOOD GAS SAMPLES ON ABL827 FLEX PLUS ANALYZER ((B)(6)): SAMPLE # (B)(6): ABL ANALYZER INCORRECT RESULT: 27G/L, LAB ANALYZER COMPARISON RESULT: 118G/L SAMPLE # 108567: ABL ANALYZER INCORRECT RESULT 121G/L, LAB ANALYZER COMPARISON RESULT 67G/L SAMPLE # (B)(6) IS CONSIDERED FALSE HIGH AND SAMPLE (B)(6) IS CONSIDERED FALSE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982134 ↗
• MalfunctionMay 1, 2023High Readings; Low Readings; High Readings; Low Readings

  ACCORDING TO THE COMPLAINT THE CUSTOMER IS COMPLAINING ABOUT DEVIATIONS ON PARAMETER PH, PCO2 AND PO2 MEASURED ON THE ABL800 FLEX ANALYZER (SERIAL NO. (B)(6)). VALUES FOR PH, PCO2 AND PO2 DIFFER BETWEEN TWO MEASUREMENTS FROM THE SAME PATIENT. THE CUSTOMER STATES THAT THE VALUES MEASURED DURING THE SECOND MEASUREMENT DO NOT MATCH WITH THE PATIENT'S CONDITION. FOLLOWING TABLE REGARDING THE TWO MEASUREMENTS CARRIED OUT: (B)(6). BASED ON THE MEASUREMENT RESULTS THE RESULTS OF 7,33 (PH) AND 155 MMHG (PO2) MEASURED ON THE ABL800 FLEX ANALYZER IS CONSIDERED FALSE HIGH. THE 53,2 MMHG (PCO2) IS CONSIDERED FALSE LOW. AT A FOLLOW UP VISIT RADIOMETER FIELD SERVICE ENGINEER CLEANED THE ABL800 FLEX ANALYZER AND REPLACED THE PO2 ELECTRODE AND PCO2 SEALING RING AND MEMBRANE, PH SEALING RING AND REFERENCE MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842600 ↗
• MalfunctionApr 20, 2023High Readings; High Readings

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2023 WHEN USING AN (B)(6) THE CUSTOMER REPORTED A POTENTIAL BIAS FOR NA (SODIUM) ON THIS ANALYZER WHICH IS UNDETECTED BY CALIBRATION AND BOTH INTERNAL AND EXTERNAL QC. ALL PATIENT RESULTS WERE ELEVATED BY 6-10 MMOL/L IN REFERENCE TO THE LAB VALUE. ABL800 LAB UNIT 148 137 MMOL/L. 153 136 MMOL/L. 148 130 MMOL/L. 156 145 MMOL/L. THE CUSTOMER REPORTED THE 4 RESULTS FROM THE ABL800 AS FALSE HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775059 ↗
• MalfunctionJun 14, 2022High Readings; High Readings

  ON 31-MAY-2022, 10:22PM THE ABL800 (SERIAL NUMBER: (B)(4)) REPORTED A RESULT FOR NA+ OF 174 MMOL/L. SAME DAY AT 10:29PM A COMPARISON RESULT ON ANOTHER ABL ANALYZER WAS 137 MMOL/L. THE CUSTOMER REPORTED THE FIRST RESULT AS FALSE HIGH. ACCORDING TO THE COMPLAINT, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684100 ↗
• MalfunctionMar 28, 2022High Readings; High Readings

  ACCORDING TO THE COMPLAINT A CUSTOMER CALLED TO REPORT THAT AFTER A POTENTIALLY HAEMOLYSED SAMPLE HAD BEEN RUN THROUGH THE ANALYSER THEY HAD FOUR PATIENT RESULTS WHICH GAVE ABNORMALLY HIGH ELECTROLYTE RESULTS, THE VALUES WERE: K - 7.1, 5.8, 6.3 & 8.0 MMOL/L, NA - 230, 224, 233 & 236 MMOL/L, CA - 2.96, 2.45, 2.76 & 2.81 MMOL/L,AND CL - 107, 106, 105 & 104 MMOL/L. REFERENCE VALUES FOR 2 PATIENTS PATIENT 1: K 7.1 MMOL/L DISCREPANT , K 4.3 MMOL/L COMPARISON, NA 230 MMOL/L DISCREPANT , NA 131 MMOL/L COMPARISON, CA 2.96 MMOL/L DISCREPANT , CA 1.21 MMOL/L COMPARISON, CL 107 MMOL/L DISCREPANT ,AND CL 102 MMOL/L COMPARISON. PATIENT 2: K 8.0 MMOL/L DISCREPANT , K 4.9 MMOL/L COMPARISON, NA 236 MMOL/L DISCREPANT , NA 135 MMOL/L COMPARISON, CA 2.81 MMOL/L DISCREPANT , CA 1.19 MMOL/L COMPARISON, CL 104 MMOL/L DISCREPANT ,AND CL 98 MMOL/L COMPARISON. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928281 ↗
• InjuryMar 2, 2022Leak/Splash; Detachment of Device or Device Component; Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER STATED THAT THE WASTE LINES WERE POPPING OFF THE CONNECTOR. HE GOT SPLASHED/SPRAYED BY WASTE LINE IN THE EYES/FACE AND HAD TO RINSE THE EYES.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655511 ↗
• InjuryMar 1, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER STATED THAT THE WASTE LINES WERE POPPING OFF THE CONNECTOR. HE GOT SPLASHED/SPRAYED BY WASTE LINE IN THE EYES/FACE AND HAD TO RINSE THE EYES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635240 ↗
• MalfunctionJan 28, 2022Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE COMPLAINT THE CUSTOMER COULD OBSERVE A PRESSURIZED WASTE CONTAINER. WHEN CHANGING IT, SOME OF THE CONTENTS ESCAPED FROM THE BOTTLE ENTRY PORT. THE WASTE CONTAINER IN QUESTION WAS PREVIOUSLY A S4980 RINSE SOLUTION BOTTLE. THE S4980 RINSE SOLUTION BOTTLE IS INTENDED TO BE USED AS A WASTE CONTAINER WHEN THE RINSE SOLUTION IS USED UP. THE WASTE CONSISTS OF BLOOD AND USED QC AND CALIBRATION LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384162 ↗
• MalfunctionDec 15, 2021High Readings; Output Problem; High Readings; Output Problem

  ACCORDING TO THE COMPLAINT ON (B)(6) 2021 THE CUSTOMER NOTICED FALSE HIGH MEASUREMENTS OF SODIUM ON FIVE PATIENTS ON A ABL800 FLEX ANALYZER. THE CUSTOMER NOTICED THAT THE REFENCE MEMBRANE WAS FULL OF BLOOD AND CHAMBER WAS FLOODED WITH BLOOD AND LEAKED INTO PH ELECTRODE CHAMBER. SHE CLEANED UP THE BLOOD AND REPLACED THE MEMBRANE, RAN CALIBRATIONS AND QC, THESE PASSED AND THE PATIENTS AFTER THAT WERE GOOD. THE QC AND CALIBRATIONS PASSED IN THE MORNING, SHOWING NO INDICATION OF A PROBLEM ON THE ANALYZER. THE BELOW ARE THE FALSE HIGH MEASUREMENTS OF NA+. COMPARISON MEASUREMENT/EXPECTED VALUE IS 140MMOL/L. PATIENT 1: 159 MMOL/L. PATIENT 2: 170 MMOL/L. PATIENT 3: 161MMOL/L. PATIENT 4: 157MMOL/L. PATIENT 5: 159MMOL/L. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009643 ↗
• MalfunctionDec 2, 2021High Readings; Output Problem; High Readings; Output Problem

  IN THE INITIAL MDR REPORT TWO TIMESTAMPS AND THE RELATED MEASUREMENTS OF NA WERE NOT CORRECT. THE CORRECT RESULTS AND TIMESTAMPS ARE AS FOLLOWS: (B)(6) 2021 11:01, NA, 156. (B)(6) 2021 13:06, NA, 167. (B)(6) 2021 13:10, NA, 165. (B)(6) 2021 13:13, NA, 167. (B)(6) 2021 18:48, NA, 152.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914719 ↗
• InjuryNov 16, 2021Use of Device Problem; Low Readings; Use of Device Problem; Low Readings

  ACCORDING TO THE COMPLAINT, A FALSE LOW CREATININE RESULT OF 0.35 MG/DL WAS MEASURED ON THE RADIOMETER ABL800 ANALYZER FOR A (B)(6) FEMALE PATIENT. A COMPARISON MEASUREMENT OF 9.54MG/DL WAS OBTAINED FROM THE CENTRAL LABORATORY. BASED ON THE ABL800 RESULT, THE HOSPITAL INITIATED UNNECESSARY TREATMENT WITH CONTRAST AGENT. IT WAS REPORTED THAT DUE TO THE TREATMENT THE PATIENT EXPERIENCED KIDNEY INSUFFICIENCY.

  Patient problems: Renal Impairment

  MAUDE report 12819493 ↗
• MalfunctionNov 9, 2021High Readings; High Readings

  ACCORDING TO THE COMPLAINT ON (B)(6) 2021, WHEN THE CUSTOMER MEASURED A BLOOD SAMPLE ON THE ABL800 FLEX ANALYZER, THE RESULT OF K+ WAS 8.1 MEQ/L, WHICH IS HIGHER THAN EXPECTED VALUE FOR ABOUT 4~5 MEQ/L. THEREFORE, THEY DOUBTED THE RESULT FROM THE ABL800 FLEX ANALYZER, AND THEN THEY CHECKED ANOTHER RESULT FROM THE ANALYZER ON LAB. THE RESULT OF K+ FROM LAB'S ANALYZER WAS EXPECTED VALUE. NO ADVERSE EVENT IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777887 ↗
• MalfunctionNov 7, 2021Output Problem; Output Problem

  ACCORDING TO THE COMPLAINT, THE USER EXPERIENCED DISCREPANT RESULTS FOR POTASSIUM AND SODIUM FROM THE ABL800 BLOOD GAS ANALYZER, WHEN COMPARING TO RESULTS FROM ANOTHER COMPANY'S DEVICE: THE SAME PATIENT SAMPLE WAS MEASURED ON (B)(6) 2021 AT 10:30 WITH THE FOLLOWING RESULTS: K: 10.4MMOL/L (ABL827 ANALYZER), 4.0MMOL/L (OTHER COMPANY MEDICAL DEVICE) NA: 132MMOL/L (ABL827 ANALYZER), 140.0MMOL/L (OTHER COMPANY MEDICAL DEVICE) BASED ON THE COMPARED MEASUREMENTS THE CUSTOMER CONSIDERS THE K RESULT MEASURED IN THE ABL827 ANALYZER AS FALSE HIGH AND THE NA RESULT AS FALSE LOW. NO REPORTS OF DEATH OR SERIOUS INJURY WERE RECEIVED FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758305 ↗
• MalfunctionOct 14, 2021High Readings; High Readings

  ACCORDING TO THE COMPLAINT THE PATIENT BLOOD SAMPLE TEST RESULT FOR THB WAS HIGHER FROM THE ABL800 FLEX ANALYZER THAN THE EXPECTED VALUE: 1ST: 9/27 16:35 THB: 11G/DL. 2ND: 9/27 17:07 THB: 6.3 G/DL (EXPECTED VALUE). THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FROM ANOTHER CLINIC DUE TO ANEMIA. THEN THE CUSTOMER MEASURED THIS PATIENTS BLOOD SAMPLE AND RECEIVED THE RESULT FOR THB 11 G/DL FROM THE ABL800 FLEX ANALYZER, WHICH IS HIGHER THAN EXPECTED VALUE. THE CUSTOMER DOUBTED THIS FIRST RESULT AND RE-MEASURED ANOTHER BLOOD SAMPLE FROM THE SAME PATIENT WITH THE SECOND RESULT FOR THB: 6.3 G/DL, WHICH WAS AN EXPECTED VALUE. BECAUSE THE CUSTOMER DOUBTED THE FIRST FALSE HIGH THB RESULT, THERE IS NO UNNECESSARY TREATMENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629991 ↗
• MalfunctionOct 14, 2021High Readings; High Readings

  ACCORDING TO THE COMPLAINT, WHEN THE CUSTOMER MEASURED A PATIENT BLOOD SAMPLE ON A ABL800 FLEX ANALYZER, THE RESULT OF NA+ WAS 162 MMOL/L WHICH WAS HIGHER THAN EXPECTED VALUE. THEN, THE CUSTOMER HAD A SUSPICION AND CHECKED THE ANALYZER. THE CUSTOMER NOTICED THAT LEAK SOLUTION OCCURRED FROM REF MEMBRANE. AFTER THAT, THEY CLEANED AND DISINFECTED THE ANALYZER. NOBODY TOUCHED THE LEAKED SOLUTION WITHOUT GLOVES. ACCORDING TO THE PRELIMINARY RADIOMETER INVESTIGATION OF THE RECEIVED DATA THE EXPECTED VALUE OF NA+ IS 140 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629746 ↗
• MalfunctionOct 4, 2021High Readings; Output Problem; High Readings; Output Problem

  ACCORDING TO THE COMPLAINT THE REFERENCE ELECTRODE MEMBRANE LOT 2944 WAS LEAKING BLOOD IN THE MEASURING CHAMBER AND THE CUSTOMER REPORTED THE NA RESULT WAS TOO HIGH. THE DISCREPANT MEASUREMENT FOR NA WAS 156MMOL/L. (12:27AM (B)(6) 2021) AND THE COMPARISON MEASUREMENT FOR NA 135MMOL/L (12:26AM (B)(6) 2021). CALIBRATIONS DID NOT FAIL UNTIL 5:30AM (B)(6) 2021 OF THAT MORNING. FAILED PARAMETERS CURRENTLY WERE PH, NA, CA AND K. NEXT CALIBRATION WAS GOOD. THE ON-BOARD SCHEDULE QC WAS RUN AT 6:08AM, QC LEVEL 3 AND FAILED PH, NA AND CA. THE QC LEVEL 3 WAS RE-RUN AND PASSED ALL PARAMETERS. THE NEXT ON-BOARD SCHEDULED QC WAS RUN AT 8:00AM, QC LEVEL 2 FAILED PH, K AND NA. THESE PARAMETERS WERE NOW LOCKED UNTIL A PATHOLOGY STAFF COULD GO TO THE INSTRUMENT TO PERFORM MAINTENANCE AND FIX THE PROBLEM. CUSTOMER WENT TO INSTRUMENT (ABL800 FLEX ANALYZER) AND FOUND BLOOD LEAKING FROM THE REFERENCE ELECTRODE MEASURING CHAMBER. CUSTOMER CLEANED THE BLOOD FROM THE INSTRUMENT AND REMEMBRANED THE REFERENCE ELECTRODE AT 10:30AM AND RAN QC LEVEL 2 AND LEVEL 3 AND PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567014 ↗
• MalfunctionDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE COMPLAINT, A CUSTOMER FROM A NEONATAL ICU REPORTS THAT AN ABL827 FLEX ANALYZER (754R0313N001) GAVE SPURIOUS RESULTS FOR THE NA+, ICA2+ AND TO A LESSER EXTENT K+ PARAMETER. THE SPURIOUS RESULTS WERE OBTAINED FROM 6 DIFFERENT PATIENTS THAT GAVE THE FOLLOWING RESULTS: SAMPLE #: K+ 5.1, CA++ 1.33. SAMPLE # (B)(6): NA 148, CA 1.65. SAMPLE # (B)(6): NA 153, CA1.52. SAMPLE # (B)(6): NA 148, K 5.1, CA 1.43. SAMPLE# (B)(6): K 5.5, CA 1.33. SAMPLE # (B)(6): NA 149, K 5.4, CA 1.55. THE CUSTOMER REPORTS THAT THE MEASURED RESULTS DID NOT CORRELATE WITH THE CLINICAL STATUS OF THE PATIENTS. ASSUMING ALL PATIENTS SHOULD BE IN NORMAL RANGE FOR THE NA, CA AND K PARAMETER IT IS ASSED THAT IN A WORST CASE SCENARIO THE DISCREPANCIES COULD LEAD TO HARM FOR THE PATIENTS. NONE OF THE PATIENTS WERE IMPACTED OR INJURED DUE TO THIS EVENT. PATIENTS ARE STILL ON HOSPITAL WARD UNDERGOING ONGOING TREATMENT. NO ADDITIONAL TREATMENT WERE REQUIRED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9509203 ↗
• MalfunctionJun 28, 2019Incorrect Measurement; Insufficient Device Problem Information; Incorrect Measurement; Insufficient Device Problem Information

  ON (B)(6) 2019, A CREA MEASUREMENT MEASURED ON AN ABL801 WAS WITHIN THE NORMAL RANGE AND THE PATIENT WAS PROVIDED CONTRAST AGENT FOR AN IMAGE DIAGNOSIS. HOWEVER, THE PATIENT ORIGINALLY HAD A POOR KIDNEY FUNCTION. THE DOCTOR CONFIRMED THAT THE TAKEN CONTRAST AGENT DID NOT DAMAGE THE PATIENT. THE PATIENT HAS NOT RECEIVED ANY DAMAGE AND ANY TREATMENT BASED ON THE CONTRAST AGENT. A MEASUREMENT OF 0.9 MG/DL WAS MEASURED ON THE ABL801 AND A COMPARISON MEASUREMENT IN THE LABORATORY GAVE 3.5 MG/DL. HOWEVER, ALL LEVELS OF QUALITY CONTROLS (QCS) HAD BEEN USED, DESPITE THAT CUSTOMERS HAS BEEN INSTRUCTED TO NARROW THE RANGE AND USE QC LEVEL 1. FURTHERMORE, THE ALERT FOR QC OUT OF RANGE WAS NOT SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743305 ↗
• MalfunctionDec 21, 2018False Negative Result; False Negative Result

  ACCORDING TO THE COMPLAINT, A CUSTOMER OBTAINED THE FOLLOWING CREATININE RESULTS APPLYING THE ABL800 FLEX ANALYZER: (B)(6) 2018/ 11:47H / ANALYZER SERIAL NUMBER (B)(4)/ 0.91 MG/DL / MEMBRANE LOT R824. AT 12:40H AT 2018-12-12, THE CUSTOMER CHANGED CREATININE MEMBRANES, WHICH WAS THE FIRST TIME SINCE 2018-11-29 AT 14:51H. SUBSEQUENTLY, THE VENOUS CREATININE RESULT WAS: (B)(6) 2018/ 12:40H/ ANALYZER SERIAL NUMBER (B)(4)/ 4.28 MG/DL /MEMBRANE LOT R832. BASED ON THE SERIES OF MEASUREMENTS, THE CUSTOMER REPORTS THE RESULT OF 0.91 MG/DL AS FALSE LOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188732 ↗