Alinity 03R7001Recalls & reported problems

Summary

The FDA's MAUDE database contains 498 adverse event reports that list this exact device (DI 00380740137410), received between Jun 27, 2018 and Mar 9, 2026 — classified as 4 injuries, 494 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (346 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 13, 2025Open, Classified

   Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

   Z-0961-2026 · Root cause: Software design · FDA record ↗

2. May 30, 2023Open, Classified

   There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

   Z-0613-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 498 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Computer Software Problem

  A RESULTS MIX UP OCCURRED INVOLVING TWO SAMPLE IDS. THE CUSTOMER REPORTED AN ISSUE INVOLVING INCORRECT RESULTS APPEARING IN THEIR LABORATORY INFORMATION SYSTEM (LIS) (SEACOAST LABORATORY DATA SYSTEMS). AFTER TESTING ON (B)(6) 2026, A PHYSICIAN QUESTIONED THE LIPID PANEL RESULTS ON (B)(6) 2026. THE CUSTOMER RE-RAN THE PATIENT SAMPLE, AND THE ALINITY RESULTS MATCHED THE ORIGINAL ANALYZER RESULTS, BUT DID NOT MATCH THE VALUES SHOWN IN THE LABORATORY INFORMATION SYSTEM (LIS). TO INVESTIGATE FURTHER, THE CUSTOMER ALSO RE-RAN THE COMPREHENSIVE METABOLIC PANEL (CMPN), AND AGAIN THE LIS RESULTS DID NOT MATCH. SAMPLE ID (B)(6) RECEIVED TEST RESULTS THAT DID NOT BELONG TO THIS SAMPLE. THE RESULTS THAT WERE POSTED TO SAMPLE ID (B)(6) WERE THE CORRECT RESULTS FOR SAMPLE ID (B)(6). AS A RESULT, SAMPLE ID (B)(6) DID NOT RECEIVE ITS OWN RESULTS, AND SAMPLE ID (B)(6) WAS REPORTED WITH INCORRECT RESULTS. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2026, (B)(6). TRIG = 134 MG/DL. HDL = 37 MG/DL. CHOL2 = 89 MG/DL. GLUCOSE = 145 MG/DL. CO2 = 30 MMOL/L. TBILI2 = 0.73 MG/DL. CREA2 = 0.91 MG/DL. K-C = 4.04 MMOL/L. NA-C = 142 MMOL/L. CL-C = 104 MMOL/L. ALBUMIN = 4.41 G/DL. CALCIUM = 9.2 MG/DL. TPRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546061 ↗
• MalfunctionMar 5, 2026Smoking; Sparking

  THE CUSTOMER OBSERVED THE WASTE BACKED UP AND WATER GOT IN THE EXTENSION CORD CONNECTED TO THE NON-ABBOTT UPS. THE UPS SHORT-CIRCUITED AND THE INSTRUMENT SHUT DOWN. THE EXTENSION CORD WHICH THE UPS WAS CONNECTED SHOWED SIGNS OF SMOKE, SPARKS WERE SEEN, AND A BURNING SMELL WAS DETECTED IN THE LABORATORY. THE POWER PLUG FOR THE ALINITY CI SERIES SCM WAS ALSO BURNT. THE POWER PLUG WAS REPLACED. THE INSTRUMENT WAS PLUGGED IN AND CONFIRMED IT WAS WORKING CORRECTLY. THE TECHNICIAN RECONFIGURED THE UPS AND POWER OUTLETS TO A LOCATION AWAY FROM THE WASTE. THERE WAS NO HARM TO THE USER OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524964 ↗
• MalfunctionFeb 26, 2026Melted

  THE CUSTOMER REPORTED NO DISPLAY ON THE MONITOR ON THE ALINITY CI-SERIES PROCESSING MODULE. THE CUSTOMER FOUND THE HDMI PORT APPEARED TO BE HEAT-DEFORMED/SHOWING SIGNS OF HAVING MELTED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456354 ↗
• MalfunctionJan 12, 2026Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT THEY FELT A MINOR SHOCK WHILE GOING THROUGH THE CABLES ON THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. THE CUSTOMER INDICATED THAT THE POWER WENT OUT IN THE LABORATORIES AND THE WASTE PUMP WAS NOT PLUGGED INTO THE UPS. ADDITIONALLY, THE SCM POWER SUPPLY WAS ALSO NOT CONNECTED, AND THEREFORE THERE WAS NO TOUCH SCREEN DISPLAY ON THE MONITOR. THIS CAUSED THE INSTRUMENT TO KEEP RUNNING AND THE WASTE PUMP OVERFLOWED ON THE FLOOR. THE CUSTOMER RECEIVED THE MINOR SHOCK WHEN TRYING TO POWER OFF THE ANALYZER. THE CUSTOMER CONFIRMED NO TREATMENT WAS REQUIRED AND WAS UNABLE TO DETERMINE IF IT WAS AN ELECTRICAL SHOCK VS A STATIC SHOCK. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038276 ↗
• MalfunctionJan 9, 2026Computer Software Problem

  THE CUSTOMER OBSERVED A CRUSTY BUILDUP ON THE INDUCTION HEATER PROBE AND INDICATED THAT THIS DIDN'T HAPPEN WITH THE OLD PROBES. THE INCUBATION HEATER WAS CLEANED FROM SALT BUILD UP. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022789 ↗
• MalfunctionJan 5, 2026Computer Software Problem

  THE CUSTOMER OBSERVED ERRATIC QC RESULTS AND NOTICED SALT BUILDUP ON THE INDUCTION HEATING ELEMENT. THE ISSUE OCCURRED ON THE ALINITY CI-SERIES SCM MODULE, SERIAL NUMBER (B)(6) . THE INCUBATION HEATER WAS CLEANED FROM SALT BUILD UP AND SAMPLE SYRINGE WAS REPLACED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966362 ↗
• MalfunctionDec 16, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED BENT R2 PROBE WITH NO ERRORS OR NOTIFICATION OR ALARMS. THE ISSUE OCCURRED ON THE ALINITY CI-SERIES SCM MODULE, SERIAL NUMBER (B)(6). THE ALINITY CI-SERIES SYSTEM SOFTWARE V3.6.0 , LIST NUMBER 04V20-27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820233 ↗
• MalfunctionDec 9, 2025Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: POTASSIUM APPROXIMATE REFERENCE (NORMAL) RANGE: 3.5 TO 5.1 MMOL/L. (B)(6) 2024, SID (B)(6), INITIAL RESULT (B)(6) 6.97 MMOL/L, REPEAT RESULT (B)(6) 4.81 MMOL/L. (B)(6) 2024, SID (B)(6), INITIAL RESULT (B)(6) 9.33 MMOL/L, REPEAT RESULT (B)(6) 3.70 MMOL/L. (B)(6) 2024, SID (B)(6), INITIAL RESULT (B)(6) 6.94 MMOL/L, REPEAT RESULT (B)(6) 4.48 MMOL/L. (B)(6) 2024, SID (B)(6), INITIAL RESULT (B)(6) 7.79 MMOL/L, REPEAT RESULT (B)(6) 3.86 MMOL/L. (B)(6) 2024, SID (B)(6), INITIAL RESULT (B)(6) 6.92 MMOL/L, REPEAT RESULT (B)(6) 4.44 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760682 ↗
• MalfunctionDec 8, 2025Computer Software Problem; Computer Software Problem

  ABBOTT HAS IDENTIFIED FOUR POTENTIAL ISSUES FOUND IN THE ALINITY CI-SERIES SYSTEM SOFTWARE VERSIONS 3.6.1 AND LOWER. ISSUES 1 TO 3 OCCUR ONLY ON THE ALINITY I AM PROCESSING MODULE. ISSUE 4 OCCURS ONLY ON THE ALINITY C PROCESSING MODULE. ISSUE 1: INADEQUATE WASH CYCLE CAN RESULT IN SALT BUILDUP ON THE INDUCTION HEATER (IH) ASSEMBLY WHICH CAN REDUCE SAMPLE PIPETTOR WASH PERFORMANCE, INCREASING THE RISK OF SAMPLE CARRYOVER. ISSUE 2: SMALL CHANGES IN RELATIVE LIGHT UNITS (RLU) VALUES MAY OCCUR IF A SAMPLE¿S READING COINCIDES WITH ANOTHER RV BEING INSERTED. THIS OCCURS BECAUSE RV LOADING MOVES THE PROCESS PATH DISK, ALTERING RV ALIGNMENT AT THE OPTICS AND AFFECTING RLU MEASUREMENTS. ISSUE 3: WHEN A NEW REAGENT CARTRIDGE IS LOADED, IT UNDERGOES MIXING BEFORE SAMPLING. SAMPLING SHOULD OCCUR AFTER 300 SECONDS BUT CAN OCCUR AFTER 200 SECONDS, POTENTIALLY REDUCING REAGENT HOMOGENEITY AND AFFECTING SAMPLE-REAGENT INTERACTION. ISSUE 4: THE ALINITY C PROCESSING MODULE MAY HAVE A R1 OR R2 PIPETTOR PROBE MOVEMENT RESTRICTION BUT NOT REPORT THE EXPECTED MESSAGE CODES 5744 R1 PIPETTOR MOVEMENT RESTRICTED AT (0) POSITION (1) AND 5745 R2 PIPETTOR MOVEMENT RESTRICTED AT (0) POSITION (1). IN THIS CASE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746827 ↗
• MalfunctionNov 13, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED AN EXPIRED LOT OF GLUCOSE REAGENT WHICH WAS NOT REMOVED BY THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. THE REAGENT EXPIRED ON 30 SEP 2025. QUALITY CONTROL AND PATIENTS WERE TESTED ON THE EXPIRED LOT OF REAGENTS. THE CUSTOMER RAN 26 PATIENT SAMPLES WHEN THE REAGENT WAS EXPIRED WITH INITIAL RESULTS THAT RANGED FROM 3.93 MMOL/L AND 16.60 MMOL/L. NO REPEAT RESULTS WERE PROVIDED. UPON FURTHER REVIEW, THE CUSTOMER REPORTED THAT THE SELECTION FOR OVERRIDE REAGENT LOT EXPIRATION WAS IN THE "ON" POSITION. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543951 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER WAS CHANGING THE WASTE PUMP ON THE ALINITY CI SERIES SYSTEM AND NOTICED A SUPERFICIAL CUT ON THE TIP OF THEIR LEFT RING FINGER. THE CUSTOMER WAS WEARING GLOVES. THEY WASHED WITH SOAP AND WAS PUT ON TRIPLE THERAPY MEDICATION CALLED DELSTRIGO (ANTIRETROVIRAL DRUG) FOR ONE MONTH. THE CUSTOMER WAS PRESCRIBED DELSTRIGO (ANTIRETROVIRAL THERAPY). THERE WAS NO FURTHER IMPACT TO THE USER/OPERATOR REPORTED.

  Patient problems: Abrasion

  MAUDE report 23508794 ↗
• MalfunctionJul 7, 2025Installation-Related Problem; Installation-Related Problem

  THE CUSTOMER OBSERVED A SOFTWARE ISSUE ON THE ALINITY CI-SERIES SYSTEM CONTROL MODULE IN WHICH THE COMMA/DECIMAL CONFIGURATION INCORRECTLY CAUSED A FALSELY DEPRESSED RESULT FOR CK. THE CK RESULT SHOWED 6.230 U/L AND SHOULD BE 6230 U/L. THE RESULT WAS NOT RELEASED AS DURING VALIDATION OF THE RESULT THE CUSTOMER NOTICED IT DID NOT MATCH THE PATIENT HISTORY. THE FIELD SERVICE REPRESENTATIVE HAD REPLACED THE DRIVE DUE TO A BLUE SCREEN ERROR AND AFTER INSTALLING SW 3.6 DID NOT CHANGE THE CONFIGURATION FROM THE DEFAULT TO THE CUSTOMER¿S PREVIOUS CONFIGURATION FOR COMMA/DECIMAL. THE SETTING HAS BEEN CORRECTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417191 ↗
• MalfunctionMay 12, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED BY THE ALINITY CI-SERIES SCM MODULE FOR A PATIENT. IT WAS OBSERVED THAT THE DILUTION FACTOR WAS APPLIED TO ADD ON ORDERS, FROM A PREVIOUS MANUAL ORDER. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2025 SAMPLE ID (B)(6) GLUCOSE RESULT = >800, MANUAL 1:5 DILUTION WAS ORDERED AND RESULT = 1300. CUSTOMER IS NOT QUESTIONING THIS RESULT AND 1300 WAS REPORTED OUT. MAGNESIUM (MG) ADD ON ORDER FOR THE SAME SID (B)(6) WAS COMPLETED ON THE LIS BEAKER SYSTEM. THE 1:5 DILUTION FACTOR WAS ALSO APPLIED TO THIS ORDER AND RESULT OF 12 MG/DL WAS OBTAINED. THE CUSTOMER WAS NOT AWARE THAT THE DILUTION FACTOR WAS STILL ENTERED INTO THE SOFTWARE WHEN THIS RESULT WAS RUN. SAMPLE WAS RUN NEAT AND RESULT = 2.6 MG/DL. CUSTOMER¿S REFERENCE RANGE IS 1.8-2.6 MG/DL. CUSTOMER STATES THAT THE SAME ISSUE HAPPENED ON (B)(6) 2025, A KNOWN FERRITIN SAMPLE (SAMPLE ID (B)(6)) THAT NEEDS TO BE RUN DILUTED WAS RUN WITH MANUAL 1:20 DILUTION. FERRITIN RESULT WAS NOT QUESTIONED OR DISCREPANT. THERE WAS AN ADD ON FOR CMP FOR THE SAME SID, AND ALL RESULTS HAD THE 1:20 DILUTION FACTOR APPLIED WHICH GENERATED ERRONEOUS RESULTS. CUSTOMER DID NOT REPORT OUT CMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005427 ↗
• MalfunctionApr 10, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED AN INCORRECT PATIENT NAME DISPLAYED ON THE ALINITY CI-SERIES SYSTEM CONTROL FOR ONE DONOR. WHEN SAMPLE ID: (B)(6) (PATIENT NAME: (B)(6) WAS LOADED ONTO THE SYSTEM, THE PATIENT¿S NAME DISPLAYED AS (B)(6) (INCORRECT) INSTEAD OF (B)(6) (CORRECT). THE CUSTOMER STATED THE PATIENT¿S NAME IN THE LABORATORY INFORMATION SYSTEM (LIS) WAS ACCURATE. THERE WAS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815116 ↗
• MalfunctionMar 20, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT WHILE CLEANING THE HOSES ON THE EXTERNAL WASTE PUMP WITH AN ALINITY CI-SERIES SYSTEM CONTROL MODULE, AN EMPLOYEE WAS SPRAYED IN THE EYE WITH THE HIGH-CONCENTRATION WASTE HOSE. IT WAS REPORTED THAT THE INDIVIDUAL IMMEDIATELY RINSED WITH THE EYEWASH STATION. THE INDIVIDUAL WENT TO THE EMERGENCY ROOM AND HAD THEIR EYES EXAMINED AND LABORATORY BLOOD WORK TAKEN. NO FURTHER TREATMENT OR INTERVENTION WAS REPORTED THE CUSTOMER REPORTED THAT THERE ARE NO EYE COMPLAINTS FOR THE INDIVIDUAL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21654016 ↗
• MalfunctionMar 3, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: SID (B)(6) = 102 / 138.9 MMOL/L, REPEATED 8X WITH RESULTS AROUND 139, EXCEPT ONE VALUE OF 119 MMOL/L (REFERENCE RANGE: 133-146 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502638 ↗
• MalfunctionJan 31, 2025Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT AN INCORRECT MICROALBUMIN RESULT FOR SID (B)(6) WAS RELEASED BY THE ALINITY CI-SERIES SYSTEM CONTROL MODULE INTO THE ALINIQ AMS SOFTWARE FOR A PATIENT. ON (B)(6) 2025, SID (B)(6) GENERATED A MICROALBUMIN RESULT OF <5.0 MG/L, WHICH WAS RELEASED INTO THE ALINIQ AMS SOFTWARE. THE NEXT SAMPLE (SID (B)(6)) GENERATED A MICROALBUMIN RESULT OF 28.5 MG/L, WHICH WAS RELEASED INTO THE ALINIQ AMS SOFTWARE UNDER SID (B)(6). CONSEQUENTLY, THE MICROALBUMIN RESULT FOR SID (B)(6) WAS REPORTED OUT OF THE LAB AS 28.5 MG/L (INCORRECT RESULT) INSTEAD OF <5.0 MG/L (CORRECT RESULT). THE CUSTOMER HAS SINCE AMENDED THE PATIENT REPORT. THE ABBOTT SERVICE TEAM WAS UNABLE TO DETERMINE IF THE ISSUE WAS CAUSED BY THE ALINIQ AMS SOFTWARE OR THE ALINITY CI-SERIES SYSTEM CONTROL MODULE, SO THIS INCIDENT WILL BE REPORTED UNDER BOTH PRODUCTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285125 ↗
• MalfunctionJan 16, 2025Smoking; Smoking

  THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED SMOKE COMING FROM THE BACK OF THE MONITOR FOR THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. WHILE ONSITE AND WORKING ON ANOTHER ANALYZER, THE CUSTOMER CYCLED POWER TO SYSTEM. UPON REBOOT, CUSTOMER REPORTED SCREEN WENT BLANK. FSR NOTICED SMOKE COMING FROM BACK OF THE MONITOR. FSR UNPLUGGED AND REMOVED THE MONITOR FROM THE SYSTEM PROMPTLY. WHEN REMOVING THE MONITOR AND CABLE, DAMAGE TO THE CABLE WAS NOTICED. THE MONITOR WAS REPLACED BUT THE SCREEN STAYED BLANK. REPLACED UIC. SCREEN CAME BACK NORMALLY. NO IMPACT TO USER SAFETY/PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172240 ↗
• MalfunctionJan 2, 2025Computer Software Problem; Low Test Results; Computer Software Problem; Low Test Results

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024, TWO PATIENT SAMPLES WERE TESTED FOR A BASIC CHEMISTRY PANEL. THE 2 SAMPLES WERE BOTH RUN CORRECTLY ON THE ALINITY C PROCESSING MODULE, HOWEVER ONCE THE RESULTS WERE TRANSMITTED FROM THE INSTRUMENT TO THE ALINITY CI-SERIES SYSTEM CONTROL, BOTH PATIENTS HAD THE SAME THE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED: BOTH SAMPLES WERE RUN ON ALINITY C PROCESSING MODULE (SN (B)(6)). PATIENT #1: SID (B)(6) (DIABETIC). PATIENT #2: SID (B)(6) (NON-DIABETIC). THE PHYSICIAN FOR THE DIABETIC PATIENT (SID (B)(6)) NOTIFIED THE CUSTOMER AND SAID THIS PATIENT NEVER HAD A GLUCOSE UNDER 200 MG/DL. THE CUSTOMER LOOKED BACK AT THE INSTRUMENT LOGS AND THE ACTUAL RESULT FROM THE INSTRUMENT WAS 270 MG/DL WHICH BELONGED TO THE DIABETIC PATIENT (SID (B)(6)). THE GLUCOSE RESULT OF 66 MG/DL BELONGED TO PATIENT #2 (SID (B)(6)). THE CUSTOMER STATED THAT IT APPEARED WHEN THE RESULTS WERE TRANSMITTED FROM THE INSTRUMENT TO THE ALINITY CI-SERIRES SYSTEM CONTROL, THE RESULTS FROM SID (B)(6) WAS USED FOR BOTH PATIENTS. THE PATIENT¿S CHART HAS BEEN AMENDED FOR SID (B)(6). THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057048 ↗
• MalfunctionNov 4, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED A BARCODE READ ERROR ON THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. THE BARCODE READER WAS REPLACED AND AFTER THIS IS WHEN THE CUSTOMER NOTICED THE SAMPLES WERE BEING ANALYZED IN THE REVERSE ORDER, THEREFORE INCORRECTLY READ, AND ASSIGNED. THE PATIENT SAMPLES IN THAT RACK WERE REPEATED ON ANOTHER ANALYZER TO VERIFY THE RESULTS. THE FOLLOWING EXAMPLES WERE GIVEN: SAMPLE ID (B)(6) MALE CRP HS (REFERENCE RANGE 0-0.5 MG/DL) INITIAL RESULT = 0.05 MG/DL; RERAN ON OTHER ALINITY AND RESULT = 0.90 MG/DL. SAMPLE ID (B)(6) MALE ALKP (REFERENCE RANGE 40-150 U/L) INITIAL RESULT = 74 U/L; RERAN ON OTHER ALINITY AND RESULT = 85 U/L. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600275 ↗
• MalfunctionNov 1, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED THE UREA NITROGEN ASSAY PARAMETERS AUTOMATICALLY DOWNLOADED INCORRECTLY TO THE ALINITY CI SYSTEM CONTROL MODULE AFTER A SOFTWARE UPDATE. THE CUSTOMER OBSERVED AFTER THE SOFTWARE UPDATE ON (B)(6) 2024 AT 2:00 P.M. THE CORRELATION FACTOR WAS RESTORED TO 1 WITH NO NOTIFICATION WHILE KEEPING THE LINEARITY LIMITS APPROPRIATE FOR THE CORRELATION FACTOR OF 2.14. AFTER THE CUSTOMER RAN QUALITY CONTROLS, THE UREA NITROGEN RESULTS WERE LOW COMPARED TO THE EXPECTED MEANS. THE RESULTS WERE NOT MULTIPLIED BY THE EXPECTED CORRELATION FACTOR OF 2.14 AND WERE NOT ALIGNED WITH THE CUSTOMER¿S REFERENCES. AFTER CORRECTING THE FACTOR, IT WAS NECESSARY TO RECALIBRATE THE ASSAY SO THAT IT WAS APPLIED TO THE RESULTS. THE FOLLOWING SIDS WERE PROVIDED: (B)(6) HOWEVER, NO SPECIFIC DATA RESULTS WERE PROVIDED AT THIS TIME. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588216 ↗
• MalfunctionOct 30, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT SHE WAS SPLASHED IN THE FACE WHILE DISCONNECTING A WASTE TUBING FROM THE EXTERNAL WASTE PUMP WHICH WAS ATTACHED TO THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. THE EXTERNAL WASTE PUMP WAS GENERATING ERRORS AND LEAKING. THE CUSTOMER WAS IN THE PROCESS OF REPLACING THE EXTERNAL WASTE PUMP WHEN THE LIQUID FROM THE WASTE TUBING SPLASHED HER FACE. THE CUSTOMER WAS WEARING A LAB COAT, GLOVES, AND GOGGLES AT THE TIME OF THE INCIDENT. SHE IMMEDIATELY WASHED HER FACE AND EYES WITH AQUA DEST (STERILE WATER). THE CUSTOMER STATED THAT SHE IS DOING FINE. SHE DID NOT SEEK ANY TREATMENT OTHER THAN WASHING HER FACE AND EYES WITH STERILE WATER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574225 ↗
• MalfunctionOct 22, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED PHOSPHORUS CONTROLS AND PATIENT SPECIMENS RAN ON EXPIRED PHOSPHORUS REAGENT WITHOUT ANY FLAGGING WITH RESULTS FROM ALINITY CI PROCESSING MODULE. THE CUSTOMER NOTICED THE PHOSPHORUS2 REAGENT LOT NUMBER EXPIRED ON 28SEP2024. THE CONTROLS AND PATIENT SPECIMENS RAN ON (B)(6)2024 FROM EXPIRED PHOSPHORUS2 REAGENT WITHOUT ANY FLAGGING WITH RESULTS. THE RESULTS PROVIDED WERE: ON (B)(6)2024, SID (B)(6), INITIAL=1.3 MG/DL /REPEATED AFTER NEW REAGENT LOT NUMBER OF PHOSPHORUS REAGENT=1.3 MG/DL. SID (B)(6), INITIAL=2.7 MG/DL /REPEATED ON AFTER NEW REAGENT LOT NUMBER OF PHOSPHORUS REAGENT=2.8 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502883 ↗
• MalfunctionJun 26, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED INCORRECT TRANSMISSION OF RESULTS FROM THE ALINITY CI-SERIES SYSTEM CONTROL AFTER A SOFTWARE UPDATE (VERSION 3.5.3). THE CUSTOMER STATED THE OTHER ALINITY ON THE OLDER VERSION SOFTWARE WAS REPORTING NORMALLY. THE CUSTOMER REPORTED THAT ONLY ONE SAMPLE NEEDED TO BE CORRECTED. ALL OTHER SAMPLES WERE NOT RELEASED. THE FOLLOWING DATA WAS PROVIDED: PATIENT REFERENCE RANGE FOR FERRITIN: 10-120 UG/L ALL FERRITIN SAMPLES WERE >1675 BUT TRANSMITTED TO >1 IN THE SUNQUEST LIS. SAMPLE ID (B)(6) WAS THE ONLY SAMPLE RELEASE TO DOCTOR THAT NEEDED TO BE CORRECTED. DOCTOR DID NOT TREAT PATIENT BASED ON THIS RESULT. THE OTHER SAMPLE IDS THAT DID NOT GET RELEASED WERE: (B)(6). PATIENT REFERENCE RANGE FOR B12: 213-816 PG/ML SAMPLE ID (B)(6): ALINITY RESULT = 1374 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML; SAMPLE ID (B)(6): ALINITY RESULT = 1192 PG/ML; SUNQUEST LIS RESULT = <148 PG/ML. PATIENT REFERENCE RANGE ALKALINE PHOSPHATASE: 32-92 U/L. SAMPLE ID (B)(6): ALINITY RESULT = >1650 U/L; SUNQUEST LIS RESULT = <9. THE FIELD SERVICE ENGINEER HAD THE CUSTOMER CHANGE THE NUMERICAL FORMAT AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619433 ↗
• MalfunctionJun 25, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED A BARCODE READER ERROR ON THE ALINITY CI-SERIES SYSTEM CONTROL MODULE. THE CUSTOMER STATED THE BARCODES ON SAMPLES WERE INCORRECTLY READ AND INCORRECTLY ASSIGNED. THE BARCODE READER WAS REPLACED ACCORDING TO INSTRUCTIONS AND BARCODES WERE SCANNED CORRECTLY. THE INSTRUMENT THEN READ THE BARCODES ON THE RACK EXACTLY OPPOSITE (FROM 6-1), WITH SAMPLE 1, SAMPLE ID (B)(6)S RACK R9685 POSITION 1 BEING MISREAD AS SAMPLE 6, SAMPLE ID 2401585884 RACK R9685 POSITION 6, WHICH CAUSED THE SAMPLES TO NOT BE ASSIGNED CORRECTLY. THE ERROR WAS CORRECTED AFTER THE ANALYZER WAS RESTARTED. THE PATIENT SAMPLES IN THAT RACK WERE REPEATED ON ANOTHER ANALYZER TO VERIFY THE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610293 ↗