Elecsys TSH Assay 11731459122Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04015630899661), received between Jul 11, 2018 and Aug 1, 2022 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (22 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY AND ELECSYS FT4 III ASSAY RESULTS FROM 24 PATIENTS ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE CLIENT HAS BEEN RECEIVING COMPLAINTS FROM PHYSICIANS ABOUT ELEVATED RESULTS. SAMPLES ARE BEING SENT TO ANOTHER LAB USING DIFFERENT ANALYZERS. WHEN RESULTS HAVE BEEN COMPARED BETWEEN THREE DIFFERENT ANALYZERS, THE CLINICAL INTERPRETATION IS NOT CONSISTENT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THIS MEDWATCH IS FOR THE ELECSYS TSH ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FT4 III ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142181 ↗
• MalfunctionMar 8, 2022Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW ELECSYS TSH ASSAY RESULT FOR ONE PATIENT SAMPLE FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.225 UIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. BASED ON THE RESULT, THE ENDOCRINOLOGIST SUGGESTED LOWERING THE PATIENT'S SYNTHROID MEDICATION FROM 88 MCG TO 77 MCG. THE PATIENT QUESTIONED THE RESULT AS SIX MONTHS EARLIER THE RESULT WAS 3.26 UIU/ML AND ALL PREVIOUS RESULTS OVER THE SEVERAL YEARS PRIOR WERE CONSISTENT. THE PATIENT HAD NOT CHANGED THE DOSAGE OF MEDICATION OR ALTERED THE WAY IN WHICH MEDICINE WAS TAKEN. THE PATIENT ASKED FOR REPEAT TESTING AND A NEW SAMPLE WAS DRAWN ON (B)(6) 2022 AND TESTED ON AN UNKNOWN ANALYZER. THE RESULT WAS 1.66 UIU/ML AND WAS BELIEVED TO BE CORRECT AS IT WAS MORE IN LINE WITH PREVIOUS RESULTS. NO CHANGES WERE ACTUALLY MADE TO THE PATIENT'S MEDICATIONS BASED ON ANY OF THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13686340 ↗
• MalfunctionOct 28, 2020High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE HIGH ELECSYS TSH ASSAY RESULT FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER.

  Patient problems: Insufficient Information

  MAUDE report 10749637 ↗
• MalfunctionJul 28, 2020Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. ERRONEOUS LOW RESULTS WERE GENERATED FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY ON A COBAS 8000 E 801 MODULE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10331933 ↗
• MalfunctionJul 28, 2020Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY ON A COBAS 8000 E 602 MODULE AND A COBAS 6000 E 601 MODULE. THE PATIENT'S AGE WAS REQUESTED, BUT WERE NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENTS' RACES WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENTS' ETHNICITIES WAS REQUESTED, BUT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10331868 ↗
• MalfunctionApr 24, 2020Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. QUESTIONABLE LOW RESULTS WERE GENERATED BY THE ELECSYS TSH ASSAY ON 2 COBAS 6000 E601 MODULES. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS. THE PATIENTS' AGES RANGED FROM "20'S" YEARS TO 82 YEARS. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THERE WAS 1 FEMALE AND 1 MALE. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9996229 ↗
• MalfunctionApr 24, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>5</NOE> MALFUNCTION EVENTS. QUESTIONABLE HIGH RESULTS WERE GENERATED BY THE ELECSYS TSH ASSAY ON 3 COBAS 6000 E601 MODULES, 3 COBAS E411 ANALYZERS AND A COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 5 PATIENTS. THE PATIENTS' AGES RANGED FROM "TEENS" YEARS TO 49 YEARS. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THERE WERE 5 FEMALES. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9996202 ↗
• MalfunctionApr 23, 2020Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. QUESTIONABLE NON-REPRODUCIBLE ELECSYS TSH RESULTS WERE GENERATED BY A COBAS 8000 E 602 MODULE AND A COBAS 6000 E 601 MODULE. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS THE PATIENTS' AGES RANGED FROM 13 TO 94 YEARS. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS WERE BOTH FEMALE. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: Test Result

  MAUDE report 9991018 ↗
• MalfunctionJan 29, 2020Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>5</NOE> MALFUNCTION EVENTS. QUESTIONABLE LOW ELECSYS TSH RESULTS WERE GENERATED BY 3 COBAS 6000 E 601 MODULE ANALYZERS AND THREE COBAS 8000 E 602 MODULE ANALYZERS. THE EVENTS INVOLVED SIX PATIENT SAMPLES. 2 PATIENTS WERE AGES BETWEEN 3 AND 83 YEARS OLD. THE REMAINING PATIENTS' AGES WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THERE WERE TWO MALES AND ONE FEMALE. THE REMAINING PATIENTS' GENDERS WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641139 ↗
• MalfunctionJan 29, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>9</NOE> MALFUNCTION EVENTS. QUESTIONABLE HIGH ELECSYS TSH RESULTS WERE GENERATED BY 5 COBAS 6000 E 601 MODULE ANALYZERS, 4 COBAS 8000 E 602 MODULE ANALYZERS, 1 COBAS E 411 IMMUNOASSAY ANALYZER, AND 2 COBAS E 801 MODULE ANALYZERS. THE EVENTS INVOLVED TEN PATIENT SAMPLES. FOUR PATIENTS' AGES RANGED BETWEEN 20 AND 70 YEARS OLD. THE REMAINING PATIENTS' AGES WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT NOT PROVIDED. THERE WERE THREE MALES AND TWO FEMALES. THE REMAINING PATIENTS' GENDERS WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641133 ↗
• MalfunctionOct 25, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. QUESTIONABLE NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE ELECSYS TSH ASSAY. THE EVENTS INVOLVED A TOTAL OF 11 PATIENTS TESTED ON A COBAS 8000 E 602 MODULE AND 2 COBAS E 601 ANALYZERS. THE PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238190 ↗
• MalfunctionJul 26, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. QUESTIONABLE NON-REPRODUCIBLE RESULTS WERE GENERATED FOR THE TSH ELECSYS COBAS E 200 ASSAY. THE EVENTS INVOLVED A TOTAL OF 4 PATIENTS. THE KNOWN PATIENT'S AGE WAS (B)(6) YEARS. THERE WAS KNOWN TO BE 1 FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830187 ↗
• MalfunctionJul 26, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>4</NOE> MALFUNCTION EVENT. ERRONEOUS LOW RESULTS FOR THE TSH ELECSYS COBAS E 200 ASSAY. THE EVENTS INVOLVED A TOTAL OF FOUR PATIENTS. TWO OF THE PATIENTS' AGES RANGED FROM 14 TO 84 YEARS. THERE WAS 1 FEMALE AND 1 MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830158 ↗
• MalfunctionApr 25, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY SEVEN COBAS 6000 E 601 MODULES, A COBAS 6000 CORE UNIT, TWO COBAS 8000 E 602 MODULES, TWO COBAS E 411 IMMUNOASSAY ANALYZERS, AND TWO COBAS 8000 E 801 MODULE ANALYZERS THE EVENTS INVOLVED A TOTAL OF 13 PATIENTS WITH THE FOLLOWING: ERRONEOUS TEST RESULTS FOR FIFTEEN SAMPLES TESTED WITH THE ELECSYS TSH ASSAY. EIGHT PATIENTS' AGES RANGED FROM (B)(6) TO (B)(6). THERE WERE 5 FEMALES AND 3 MALES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549730 ↗
• MalfunctionApr 25, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS INCORRECT MEASUREMENT WAS GENERATED ON A COBAS 6000 E 601 MODULE. THE EVENT INVOLVED 1 PATIENT WHERE THE ELECSYS TSH ASSAY RESULT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549722 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>7</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY 4 COBAS 8000 E 602 MODULES, A COBAS E 411 IMMUNOASSAY ANALYZER, A COBAS E 801 MODULE, AND AN ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER. THE EVENTS INVOLVED A TOTAL OF 7 PATIENTS WITH THE FOLLOWING: SEVEN ERRONEOUS RESULTS WITH THE ELECSYS TSH ASSAY. TWO PATIENTS' AGES RANGED FROM 9 DAYS TO 39 YEARS. THERE WERE 2 FEMALES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549720 ↗
• MalfunctionApr 25, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>7</NOE> MALFUNCTION EVENTS. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED BY 3 COBAS 6000 E 601 MODULES, 3 COBAS 8000 E 801 MODULES, AND ONE COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 7 PATIENTS WITH THE FOLLOWING: 7 ERRONEOUS RESULTS FOR THE ELECSYS TSH ASSAY. THREE PATIENTS' AGES RANGED FROM 26 TO 64 YEARS. THERE WERE 2 FEMALES AND 2 MALES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549715 ↗
• MalfunctionJan 29, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS. ERRONEOUS LOW ELECSYS TSH ASSAY RESULTS WERE GENERATED. THE EVENTS INVOLVED A TOTAL OF 6 PATIENTS. THE PROVIDED PATIENTS' AGES RANGED FROM (B)(6) TO (B)(6). THE OTHER PATIENTS' AGES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THE PROVIDED PATIENT GENDERS WERE 3 FEMALES. THE OTHER PATIENTS' GENDERS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285619 ↗
• MalfunctionJan 29, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>12</NOE> MALFUNCTION EVENTS. HIGH RESULTS WERE GENERATED BY THE COBAS 8000 E 602 MODULE, THE COBAS 6000 E 601 MODULE, AN ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENT INVOLVED 14 PATIENTS WITH HIGH RESULTS FOR THE ELECSYS TSH ASSAY. THE AGES FOR 11 PATIENTS RANGED FROM (B)(6) - (B)(6). THE OTHER PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THERE WERE 6 FEMALES AND 5 MALES. THE OTHER PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8284592 ↗
• MalfunctionNov 8, 2018Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY (TSH) AND ELECSYS FT4 II ASSAY (FT4 II) ON A COBAS 6000 E 601 MODULE. BASED ON THE DATA PROVIDED, THE TSH RESULTS ARE A REPORTABLE MALFUNCTION. THE INITIAL TSH RESULT WAS 2.88 UIU/ML ON THE E601 MODULE. THE SAMPLE WAS REPEATED ON THE E601 MODULE WITH A RESULT OF 2.88 UIU/ML. ON (B)(6) 2018 THE SAMPLE WAS REPEATED ON THE E601 MODULE AND THE RESULT WAS 2.86 UIU/ML. THE CUSTOMER SENT AN ALIQUOT OF THE SAMPLE TO AN EXTERNAL LABORATORY USING THE BECKMAN COULTER METHOD AND THE TSH RESULT WAS 5.90 UIU/ML. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4). THE PINCH TUBE WAS LAST REPLACED ON (B)(6) 2018. LIQUID FLOW CLEANING WAS LAST PERFORMED ON (B)(6) 2018. RACK ADAPTERS WERE NOT USED FOR 13 MM SAMPLE TUBES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050896 ↗
• MalfunctionOct 16, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4). THE SAMPLE WAS SENT FOR TESTING ON A CENTAUR ANALYZER AND FOR INVESTIGATION ON A COBAS 8000 COBAS E 602 MODULE AND A COBAS E 411 IMMUNOASSAY ANALYZER. THIS MEDWATCH IS FOR ELECSYS TSH ASSAY. REFER TO THE MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6) FOR THE ELECSYS FT4 III ASSAY AND (B)(6) FOR THE ELECSYS FT3 III THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970765 ↗
• MalfunctionOct 15, 2018Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4) WHEN COMPARED TO THE RESULTS FROM AN (B)(4) ARCHITECT. THE RESULTS FROM THE COBAS E602 DID NOT CORRELATE WITH PATIENT SYMPTOM AND AN INTERFERENCE WAS SUSPECTED. REFER TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR ELECSYS TSH ASSAY. REFER TO THE FOLLOWING MEDWATCH WITH PATIENT IDENTIFIER FOR THE OTHER ASSAYS INVOLVED: ELECSYS T3= (B)(6). ELECSYS T4 ASSAY= (B)(6). ELECSYS FT3= (B)(6). ELECSYS FT4 ASSAY= (B)(6). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965344 ↗
• MalfunctionOct 10, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS TSH ASSAY (TSH) AND ELECSYS FT4 II ASSAY ON A COBAS 6000 E 601 MODULE. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR IS QUESTIONING THE TSH RESULTS FOR BOTH PATIENTS AS THEY DON'T CORRESPOND TO THE PROGRESSION OF TREATMENT. THE FT4 II RESULTS FOR ONE PATIENT (PATIENT 2) ARE DISCREPANT. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 II RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952285 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, ELECSYS FT3 III, AND THE ELECSYS FT4 II ASSAY AN A COBAS 6000 E 601 MODULE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PHYSICIAN REQUESTED AN INVESTIGATION OF THE SAMPLE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED FOR TSH, FT3, AND FT4 II ON A COBAS 8000 E 602 MODULE ON (B)(6) 2018. THE SAMPLE WAS REPEATED ON A CENTAUR ANALYZER AND AN ARCHITECT ANALYZER. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO THE REMAINING ASSAYS: (B)(6) = FT3, (B)(6) = FT4 II. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CUSTOMER'S E 601 ANALYZER SERIAL NUMBER IS (B)(4). THE E 602 ANALYZER USED FOR INVESTIGATION IS (B)(4). TSH REAGENT LOT NUMBER 328081, WITH AN EXPIRATION DATE OF DECEMBER 2018 WAS USED ON THIS ANALYZER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918627 ↗
• MalfunctionSep 25, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY AND THE ELECSYS FT4 II ASSAY ON AN UNKNOWN ROCHE ELECSYS ANALYZER. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. THE PATIENT SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S ROCHE ANALYZER. THE SAMPLE WAS REPEATED ON A CENTAUR ANALYZER. THE SAMPLE WAS ALSO PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A COBAS 8000 E 602 MODULE (E602). THE MODEL AND SERIAL NUMBER OF THE CUSTOMER'S ROCHE ELECSYS ANALYZER WERE ASKED FOR, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E602 ANALYZER USED FOR INVESTIGATION IS (B)(4). TSH REAGENT LOT NUMBER 328081, WITH AN EXPIRATION DATE OF DECEMBER 2018 WAS USED ON THIS ANALYZER. CALIBRATION AND CONTROLS WERE OK ON THE E602 ANALYZER USED FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.  THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  DIFFERENT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS IS RELATED TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906802 ↗