ARCHITECT 1L86-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00380740001544), received between Sep 23, 2016 and May 27, 2026 — classified as 1 injury, 168 malfunctions.

The most frequently reported specific device problem is “High Test Results” (100 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT INTACT PTH RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR A 54-YEAR-OLD FEMALE PATIENT. (NORMAL RANGE: 15- 68.3 PG/ML). THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2026 SID (B)(6) RESULTS 646.9 PG/ML, REPEAT RESULTS = 73 PG/ML AND 69.9 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298843 ↗
• MalfunctionApr 15, 2026High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I FOR 4 PATIENTS. THE CUSTOMER DOES NOT HAVE SPECIFIC PATIENT INFORMATION BUT STATES SOME PATIENTS WERE REFERRED TO ANOTHER FACILITY AND THE TROPONIN RESULTS WERE NEGATIVE. SOME PATIENTS WERE TREATED WITH HEPARIN. THERE WAS NO REPORTED HARM TO THE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) FEMALE RESULT FROM INSTRUMENT (B)(6) = 0.039 NG/ML RESULT FROM INSTRUMENT (B)(6) = 0.008 NG/ML. SID (B)(6) MALE RESULT FROM INSTRUMENT (B)(6) = 0.033 NG/ML RESULT FROM INSTRUMENT (B)(6) = 0.004 NG/ML. SID (B)(6) MALE RESULT FROM INSTRUMENT (B)(6) = 0.029/0.019 RESULT FROM INSTRUMENT (B)(6) = 0.019. SID 6330 MALE RESULT FROM INSTRUMENT (B)(6) = 0.048 RESULT FROM INSTRUMENT (B)(6) = 0.013. FEMALE REFERENCE RANGE 0.000-0.013. MALE REFERENCE RANGE 0.000-0.028 THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887353 ↗
• MalfunctionApr 14, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.00 - 0.04 NG/ML): SID (B)(6), INITIAL TROPONIN RESULT= 0.330 NG/ML; REPEAT RESULTS= 0.012 NG/ML, 0.00 NG/ML. ANOTHER SAMPLE WAS COLLECTED AND GENERATED A NEGATIVE RESULT. THE PATIENT WAS A 40 YEAR OLD MALE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874936 ↗
• MalfunctionFeb 25, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED HIGHLY SENSITIVE TROPONIN-I RESULTS WHEN PROCESSING ON THE ARCHITECT I1000SR PROCESSING MODULE. ON (B)(6) 2026, SAMPLE ID (B)(6) GENERATED 55.8 PG/ML, RERUN 2.2 PG/ML. CUSTOMER REFERENCE RANGE: MALE < 12 PG/ML AND FEMALE < 10 PG/ML. ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442327 ↗
• MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE ARCHITECT STAT TROPONIN-I RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), 73-YEAR-OLD MALE PROCESSED ON (B)(6) 2026: INITIAL RESULT PROCESSED ON ARCHITECT SERIAL NUMBER (B)(6)= 30 REPEAT 30, SAMPLE WAS THEN PROCESSED ON ARCHITECT SERIAL NUMBER (B)(6) RESULTS = 66 AND 50. SID (B)(6), 55-YEAR-OLD MALE PROCESSED ON (B)(6) 2026: INITIAL RUN ON (B)(6)= 643(NOT REPORTED) REPEAT = <20, REPEATED ON (B)(6)= <20, REDRAW FROM SAME PATIENT = <20 ON BOTH (B)(6). CUSTOMER¿S REFERENCE RANGE = 0-30 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327166 ↗
• MalfunctionDec 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) - MALE PATIENT. CUSTOMER REFERENCE RANGE MALE: < 34 NG/L. THE INITIAL RESULT WAS RESULT WAS 198.1 NG/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 16.9 AND 17.3 NG/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927527 ↗
• MalfunctionDec 29, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A MALE PATIENT. THE SAMPLE WAS RETESTED, AND SUBSEQUENT RESULTS WERE WITHIN THE NORMAL RANGE. THE PATIENT WAS REFERRED TO OTHER HOSPITALS, WHERE TROPONIN RESULTS WERE NEGATIVE. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S CUT OFF: 26 PG/ML SID (B)(6) INITIAL ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT = 1652 PG/ML REPEAT RESULTS = 9.6, 7.8, AND 8.1 PG/ML DISTRICT HOSPITAL: TROPONIN-I WAS NEGATIVE (B)(6) HOSPITAL: TROPONIN-I AND TROPONIN-C WERE BOTH NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906068 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A 70-YEAR-OLD FEMALE PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. A NEW BLOOD SAMPLE WAS TESTED YIELDED A NORMAL RESULT. THE ORIGINAL SAMPLE WAS THEN RETESTED, ALSO PRODUCING A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: <0.05 NG/ML. SID (B)(6) (FIRST DRAW): (B)(6) 2025 @ 05:56 AM INITIAL RESULT = 0.371 NG/ML, REPEAT RESULT = 0.00 NG/ML. SID (B)(6) (SECOND DRAW): (B)(6) 2025 @ 08:46AM INITIAL RESULT = 0.00 NG/ML, REPEAT RESULT = 0.00 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881934 ↗
• MalfunctionDec 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULT FOR AN 80-YEAR-OLD MALE PATIENT GENERATED ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 0.59 NG/ML (CUSTOMER'S NORMAL RANGE: < OR = TO 0.3 NG/ML) THIS RESULT WAS REPORTED OUT TO THE MEDICAL PROVIDER ON (B)(6) 2025. REPEAT TESTING ON SAME ANALYZER RESULT = < 0.01 NG/ML (NEGATIVE) QC WAS IN RANGE AT TIME OF TESTING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873242 ↗
• MalfunctionDec 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR AN 82-YEAR-OLD MALE PATIENT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND ON ANOTHER INSTRUMENT, YIELDING NORMAL RESULTS. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0.000-0.030 NG/ML SID (B)(6). (B)(6) 2025 INITIAL RESULT = 2.079 NG/ML REPEAT RESULT (SAME INSTRUMENT) = <0.030 NG/ML REPEAT RESULT (DIFFERENT INSTRUMENT) = 0.031 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837354 ↗
• MalfunctionDec 9, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL -HCG RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE ON A PATIENT. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RESULT = 4738 IU/L(POSITIVE) AND REPEAT RESULTS WERE = < 1.200, < 1.200, < 1.200 IU/L(NEGATIVE) REFERENCE RANGE: <5 IU/L= NEGATIVE AND >5IU/L POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759463 ↗
• MalfunctionDec 1, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT STAT TROPONIN-I RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE: =0.03 NG/ML, CRITICAL RANGE: =0.30 NG/ML. (B)(6) 2025 SID (B)(6) 29-YEAR-OLD FEMALE PATIENT: INITIAL RESULT = 0.82 NG/ML, NEW SAMPLE RESULT = 0.01 NG/ML. ORIGINAL SPECIMEN REPEATED ON THEIR OTHER ANALYZER, AND IT RESULTED = <0.01 NG/ML. (B)(6) 2025 SID (B)(6) 33-YEAR-OLD MALE PATIENT INITIAL RESULT = 0.38 NG/ML, RESULT 2 HOURS LATER = 0.01 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679536 ↗
• MalfunctionOct 28, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A 24-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 378.798 IU/L, REPEAT TESTING WAS NEGATIVE TWICE. THE PATIENT WAS REDRAWN TWICE, AND BOTH RESULTS WERE NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407656 ↗
• MalfunctionOct 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I1000SR INSTRUMENT FOR TWO MALE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE MALE <20 PG/ML): SID (B)(6), SUSPECTED MI, INITIAL TROPONIN RESULT (B)(6) 2025 16.97 PG/ML, REPEATED 25.54 AND 14.87 PG/ML. SID (B)(6), INITIAL TROPONIN RESULT (B)(6) 2025 8.52 PG/ML, REPEATED (B)(6) 2025 25.24 PG/ML RERUN (B)(6) 2025 8.50 PG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372276 ↗
• MalfunctionOct 2, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS <0.04 NG/ML): SAMPLE ID (B)(6) INITIAL RESULT WAS 0.11 NG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED, AND THE RESULT WAS 0.0, REPEAT, ON ANOTHER ANALYZER, WAS 0.008 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23200992 ↗
• MalfunctionSep 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TROPONIN RESULT BETWEEN DIFFERENT TUBE TYPES DRAWN AT SAME TIME FROM ONE PATIENT. THE RESULT PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL FROM YELLOW TUBE SPECIMEN=0.075 NG/ML /REPEATED=0.297 NG/ML GREEN TUBE SPECIMEN DRAWN AT SAME TIME= < 0.010 NG/ML /REPEATED= < 0.010 NG/ML THE CUSTOMER CONCERNED FOR THIS GREEN TUBE TYPE SPECIMEN RESULTS/ REDRAWN GREEN TUBE SPECIMEN SID (B)(6) INITIAL=0.029 NG/ML /REPEATED=0.030 NG/ML REDRAWN GREEN TUBE SPECIMEN SID (B)(6) =0.079 NG/ML. YELLOW TUBE SPECIMEN=0.062 NG/ML. LABORATORY REFERENCE RANGE FOR TROPONIN= < OR =0.050 NG/ML; > 0.050 NG/ML CONSIDER CARDIAC EVENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23168646 ↗
• MalfunctionSep 3, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE PATIENT. RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.030-0.118 NG/ML): ON (B)(6) 2025, SAMPLE ID: (B)(6); 1ST DRAW RESULTS= 0.013 NG/ML. ON (B)(6) 2025, SAMPLE ID: (B)(6); 2ND DRAW RESULTS = 0.181, < 0.010 ON THIS INSTRUMENT & < 0.010 ON THE ARCHITECT I1000, SN: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953588 ↗
• MalfunctionAug 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS GENERATED FOR A 55-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.00-0.05 NG/ML). B)(6) 2025; SAMPLE ID (B)(6) RESULT = 1.00 NG/ML, REPEAT RESULT ON ANOTHER INSTRUMENT I1SR56588 = 0.00 NG/ML. SAME PATIENT: SAMPLE ID (B)(6) RESULT = 0.00 NG/ML, REPEAT RESULT ON ANOTHER INSTRUMENT I1SR56588 = 0.00 NG/ML. SAMPLE ID (B)(6) WAS INITIALLY RUN MULTIPLE TIMES ON 2 DIFFERENT INSTRUMENTS, AND EVERY TIME IT GENERATED INSTRUMENT ERROR MESSAGE 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR FOR (PIPETTER) AT (SH SAMPLE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798124 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT= 402.7 NG/ML; REPEAT RESULT (REDRAWN BLOOD 20 MINUTES LATER)= 85.3 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089684 ↗
• MalfunctionMay 9, 2025Smoking; Smoking

  A LEAKING TRIGGER VALVE ON THE ARCHITECT (B)(6) PROCESSING MODULE CAUSED THE HEATER PAD TO SMOKE. NO INJURIES OR IMPACT TO THE USER WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996149 ↗
• MalfunctionMay 9, 2025Smoking; Sparking; Smoking; Sparking

  THE CUSTOMER OBSERVED SPARKS AND SMOKE COMING FROM UNDERNEATH THE ARCHITECT I1000SR WHEN PERFORMING DAILY MAINTENANCE. THE DEVICE WAS IMMEDIATELY DISCONNECTED FROM THE POWER SUPPLY. IT WAS OBSERVED THAT THE CABLE FEEDING THE I1000SR POWER SUPPLY TO THE UPS WAS TWISTED AND SHOWED SIGNS OF BURNS. IT WAS CONFIRMED THAT THE SHORT CIRCUIT WAS GENERATED DUE TO DAMAGED CABLE THAT GOES FROM THE I1000SR POWER SUPPLY TO THE UPS. THE CABLE WAS REPLACED, AND THE ISSUE RESOLVED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993149 ↗
• MalfunctionMay 2, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.01-0.3 NG/ML): INITIAL TROPONIN RESULT= 0.749 NG/ML; NEW SAMPLE AFTER 2 HOURS, RESULT= 0.2 NG/ML, REPEAT RESULT <0.01 NG/ML; REPEAT OF INITIAL SAMPLE= 0.01 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951287 ↗
• MalfunctionApr 28, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS ON MULTIPLE PATIENTS. THE RESULT PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=0.084 NG/ML /REPEATED= < 0.010 NG/ML. THIS PATIENT WAS STARTED ON HEPARIN DUE TO FALSELY ELEVATED TROPONIN RESULTS. SID (B)(6) INITIAL= < 0.010 NG/ML /REPEATED=0.057 NG/ML /REDRAWN AND REPEATED=0.010 NG/ML THE CUSTOMER BELIEVES THAT 0.057 NG/ML IS DISCREPANT TROPONIN RESULT FOR THIS PATIENT. LABORATORY REFERENCE RANGE FOR TROPONIN=0.00 TO 0.028 NG/ML ALL PATIENTS ARE DOING OK. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921134 ↗
• MalfunctionApr 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ARCHITECT I1000SR INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL REFERENCE RANGE: 0.00-0.07 NG/ML): SID (B)(6): INITIAL RESULT = 0.108 NG/ML. REPEAT ON SAME ANALYZER = 0.068 NG/ML. REPEAT ON ANOTHER ANALYZER (SN (B)(6) = 0.018 / 0.016 NG/ML. THE POSITIVE TROPONIN-I RESULT WAS NOT REPORTED TO THE PATIENT¿S CHART. THE TROPONIN-I TEST WAS AN ADD ON AND THE SAMPLE WAS SITTING FOR 3 HOURS PRIOR TO TESTING. THE CUSTOMER INSPECTED THE INSTRUMENT AND DISCOVERED THE PRE-TRIGGER AND TRIGGER SOLUTION VOLUME WAS BELOW 20%. THE CUSTOMER WHILE CHANGING THE PRE-TRIGGER AND TRIGGER SOLUTION BOTTLES, THE OPAQUE CONNECTOR TUBING BROKE OFF. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885278 ↗
• MalfunctionApr 21, 2025Leak/Splash; Leak/Splash

  THE FIELD SERVICE REPRESENTATIVE (FSR) (55-YEAR-OLD MALE) REPORTED A SPLASH TO THE FACE FROM THE ARCHITECT I1000SR ANALYZER. THE CUSTOMER OBSERVED A DROP HANGING FROM THE PROBE, WHICH COULD NOT BE RESOLVED BY WIPING THE DROP OFF THE PROBE. DURING TROUBLESHOOTING THE FSR REMOVED TUBING WHICH CAUSED A SPLASH TO THE FACE AND EYES. THE FSR WAS WEARING GLASSES. THE FSR WASHED HIS FACE AND FLUSHED HIS EYES, BUT NO OTHER MEDICAL TREATMENT WAS OBTAINED. NO FURTHER IMPACT ON PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872822 ↗