Elecsys Ferritin 07027273190Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04015630939688), received between Oct 22, 2018 and Feb 23, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FERRITIN RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 359 NG/ML, AND THE REPEAT RESULT WAS 45.7 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER NOTICED THAT THE INITIAL RESULT DID NOT CROSS INTO THE SYSTEM AND WAS HIGH COMPARED TO THE PATIENT'S HISTORY, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421348 ↗
• MalfunctionFeb 12, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324882 ↗
• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.94 NG/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 191.0 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223675 ↗
• MalfunctionNov 19, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 164 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 223 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 587 NG/ML USING THE ELECSYS ASSAY. PATIENT 2 - TWO SAMPLES FROM THE SAME PATIENT WERE TESTED: ON (B)(6) -2025, THE RESULT WAS 602 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 341 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. ON (B)(6) 2025, THE RESULT WAS 373 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 212 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. PATIENT 3 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 392 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 508 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 616 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 38.4 NG/ML, PERFORMED BY AN EXTERNAL LABORATORY. ON (B)(6) 2025, THE RESULT WAS 590 N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594548 ↗
• MalfunctionSep 10, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 39 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN FERRITIN VALUES OF 9.25 NG/ML AND 9.44 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 63.3 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 47.9 NG/ML AND 39.3 NG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 98.4 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 26.9 NG/ML AND 24.9 NG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 18.1 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 27.3 NG/ML AND 29.5 NG/ML. THE FIFTH SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 28.2 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED THREE TIMES ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 40.4 NG/ML, 14.1 NG/ML, AND 14.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018031 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULT FROM THE FIRST E 801 MODULE WAS 21.3 NG/ML. THE FIRST REPEAT RESULT FROM THE SECOND E 801 MODULE WAS 14 NG/ML. THE SECOND REPEAT RESULT FROM A THIRD MODULE WAS 14.2 NG/ML. THE THIRD REPEAT RESULT FROM A FOURTH MODULE WAS 13.4 NG/ML. THE REPORTER STATED THAT THE QUESTIONABLE RESULT WAS DISCOVERED WHILE RESOLVING QC ISSUES AND PERFORMING LOT-TO-LOT STUDIES. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468471 ↗
• MalfunctionJan 28, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS E 801 MODULE, THE INITIAL RESULT WAS 158 G/L. THE REPEAT RESULT WAS 97.8 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252437 ↗
• MalfunctionJan 13, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 MODULE. THE REPORTER PROVIDED TWO EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 (PATIENT 1): INITIAL RESULT: 55.1 UG/L. 1ST REPEAT RESULT: 25.8 UG/L. 2ND REPEAT RESULT: 25.2 UG/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 116 UG/L. REPEAT RESULT: 69.4 UG/L. THE CUSTOMER NOTICED THAT THE INITIAL RESULTS WERE HIGH. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138260 ↗
• MalfunctionJul 22, 2024High Test Results; Output Problem; High Test Results; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A CHEMILUMINESCENCE METHODOLOGY AT A DIFFERENT FACILITY. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 737 NG/ML. 1ST REPEAT RESULT: 709 NG/ML. 2ND REPEAT RESULT: 422.2 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 375 NG/ML. 1ST REPEAT RESULT: 359 NG/ML. 2ND REPEAT RESULT: 232.0 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 174 NG/ML. REPEAT RESULT: 92.8 NG/ML (TESTED WITH CHEMILUMINESCENCE). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE INITIAL RESULTS WERE CONSIDERED CORRECT AND REPORTED OUTSIDE THE LABORATORY. ONLY 1 PATIENT QUESTIONED THEIR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792657 ↗
• MalfunctionMar 29, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERRITIN) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.07 UG/L. THE INITIAL RESULT WAS NOT BELIEVED AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 278 UG/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003604 ↗
• MalfunctionMar 15, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE FERRITIN ELECSYS E2G RESULTS FROM THE COBAS E 801 MODULE. THE RESULT WAS 940 NG/ML. USING A DIFFERENT SAMPLE FROM THE SAME VENIPUNCTURE, THE RESULT FROM AN ABBOTT ANALYZER WAS 594 NG/ML. USING ANOTHER COBAS ANALYZER, THE RESULT WAS 866 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914588 ↗
• MalfunctionJan 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. INITIAL RESULT: 1.69 NG/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER NOTICED THAT THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 49.0 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18538807 ↗
• MalfunctionJan 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 3 PATIENT SAMPLES ON TWO COBAS E 801 ANALYTICAL UNITS. FOR SAMPLE 1, THE INITIAL FERRITIN RESULT WAS 4.93 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 118 NG/ML. FOR SAMPLE 2, THE INITIAL FERRITIN RESULT WAS 1.59 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 30.5 NG/ML. FOR SAMPLE 3, THE INITIAL FERRITIN RESULT WAS 2.66 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 56.0 NG/ML. THE RESULTS FOR SAMPLES 1 AND 2 WERE PRODUCED BY ANALYZER SERIAL NUMBER (B)(6). THE RESULTS FOR SAMPLE 3 WERE PRODUCED BY ANALYZER SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474015 ↗
• MalfunctionJan 2, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 4.46 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 96.7 NG/ML AND 100 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 0.500 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 7.03 NG/ML AND 7.63 NG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 0.863 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 13.2 NG/ML AND 14.2 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427852 ↗
• MalfunctionJul 25, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN (FERRITIN) RESULT FROM ONE PATIENT SAMPLE TESTED ON AN UNSPECIFIED COBAS ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE PATIENT'S FERRITIN RESULT SEEMED ABNORMALLY HIGH PROMPTING THEM TO SEND THE PATIENT TO TWO OTHER LABORATORIES: LABORATORY 1 WHICH USES AN ABBOTT ANALYZER AND LABORATORY 2 WHICH USES A VITROS ANALYZER. THE LABORATORY METHODS USED ARE UNKNOWN. THE INITIAL RESULT FROM THE CUSTOMER'S ROCHE ANALYZER WAS 584 UG/ML (REFERENCE RANGE: 20-300 UG/ML). THE REPEAT RESULT FROM LABORATORY 1'S ABBOTT ANALYZER WAS 590 UG/ML (REFERENCE RANGE: 22 ¿ 275 UG/ML). THE REPEAT RESULT FROM LABORATORY 2'S VITROS ANALYZER WAS 377 UG/ML (REFERENCE RANGE: 17.9 ¿ 464 UG/ML). THIS REPEAT RESULT WAS DEEMED CORRECT AS IT MATCHES THE PATIENT'S "CLINICAL CONTEXT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389120 ↗
• MalfunctionMar 10, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN (FERRITIN) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER 20X6-04. THE INITIAL RESULT WAS REPORTED TO THE MEDICAL PERSONNEL AND WAS REJECTED AS IT DID NOT FIT THE MEDICAL STATE AND THE PREVIOUS RESULTS OF THE PATIENT. THE INITIAL RESULT OF THE UNDILUTED SAMPLE WAS 64.5 NG/ML. THE FIRST REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 2000 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT USING A DILUTED SAMPLE WAS 4370 NG/ML. THIS REPEAT RESULT WAS DEEMED CORRECT AS IT IS IN LINE WITH THE PREVIOUS RESULTS AND THE CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522830 ↗
• MalfunctionDec 12, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS FERRITIN ASSAY ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). THE RESULTS MEASURED ON THE E 801 ANALYZER DID NOT AGREE WITH OTHER PARAMETERS FOR THE PATIENT AND DID NOT COMPARE TO THE RESULT OBTAINED WITH A COMPETITOR METHOD. ON (B)(6) 2022 A SAMPLE WAS MEASURED ON THE COBAS E 801 ANALYZER, RESULTING IN A FERRITIN VALUE OF <0.500 G/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED SEVEN TIMES, EVERY TIME RESULTING IN A VALUE OF <0.500 G/L, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2022 A SAMPLE WAS MEASURED ON THE COBAS E 801 ANALYZER, RESULTING IN A FERRITIN VALUE OF <0.500 G/L, ACCOMPANIED BY A DATA FLAG. IT WAS ASKED BUT IT IS UNKNOWN IF THE SAMPLES FROM (B)(6) 2022 DERIVE FROM THE SAME OR DIFFERENT BLOOD DRAWINGS OF THE PATIENT. A SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, RESULTING IN A FERRITIN VALUE OF 11 G/L. IT WAS ASKED BUT IT IS UNKNOWN WHICH SAMPLE WAS REMEASURED ON THE COMPETITOR ANALYZER. IT WAS ASKED BUT IT IS UNKNOWN WHETHER A QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958083 ↗
• MalfunctionDec 6, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS FERRITIN ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 1372 G/L. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN FERRITIN VALUES OF 162 G/L AND 154 G/L. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE FERRITIN REAGENT LOT WAS 60273101 WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924179 ↗
• MalfunctionNov 17, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS FERRITIN, ELECSYS TSH, AND ELECSYS FT4 III ON A COBAS E 801 MODULE. PATIENT 1 INITIAL FERRITIN RESULT WAS 18.7 NG/ML. THE REPEAT RESULT FROM A DIFFERENT INSTRUMENT WAS 885.00 NG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. PATIENT 1 INITIAL TSH RESULT WAS 0.0388 UIU/ML. THE REPEAT WAS 6.71 UIU/ML. THE REPEAT RESULT FROM A DIFFERENT INSTRUMENT WAS 7.25 UIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. ON (B)(6) 2022 PATIENT 2 INITIAL FT4 III RESULT WAS 0.0511 NG/DL. THE REPEAT RESULT WAS 1.13 NG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FERRITIN REAGENT LOT WAS 602731. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE TSH REAGENT LOT WAS 639169. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FT4 III REAGENT LOT WAS 630888. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818467 ↗
• MalfunctionOct 24, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERRITIN) ON A COBAS E801 MODULE. THE INITIAL RESULT WAS 0.500 NG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM THE SAME INSTRUMENT WAS 58.4 NG/ML. THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 60.5 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FERRITIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662747 ↗
• MalfunctionOct 7, 2022Device Damaged Prior to Use; High Test Results; High Readings; Manufacturing, Packaging or Shipping Problem; Device Damaged Prior to Use; High Test Results; High Readings; Manufacturing, Packaging or Shipping Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FERRITIN (FERRITIN) RESULTS FOR 57 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE PATIENT SAMPLES WERE RUN USING A PARTICULAR REAGENT PACK. ON (B)(6) 2022, THE PATIENT SAMPLES WERE RERUN USING A NEW REAGENT PACK WITH THE SAME LOT NUMBER. THE REPEAT RESULTS WERE NOTED TO BE 30-40% LOWER THAN THE INITIAL RESULTS. THE INITIAL RESULTS WERE CORRECTED. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A DISCREPANT RESULT: THE INITIAL RESULT WAS 18.00 UG/L. THE REPEAT RESULT WAS 10.00 UG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563701 ↗
• MalfunctionOct 22, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS FERRITIN RESULT FROM 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE. THE INITIAL FERRITIN RESULT WAS 0.2 NG/ML. THE SAME PATIENT SAMPLE WAS TESTED ON ANOTHER COBAS E801 AND A FERRITIN RESULT OF 54 NG/ML WAS OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE FERRITIN RESULT OF 54 NG/ML WAS DETERMINED TO BE PLAUSIBLE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FERRITIN REAGENT LOT WAS 30832700 WITH AN EXPIRATION DATE OF 31-JUL-2019. THE FIELD ENGINEERING SPECIALIST DETERMINED THE ERROR WAS CAUSED BY THE VALVES ON TOP OF THE REAGENT PROBE SYRINGES. THE VALVES WOULD GET STUCK FROM TIME TO TIME CAUSING INCORRECT REAGENT PIPETTING. HE REPLACED THE AFFECTED VALVES AND THE ISSUE HAS BEEN CONSIDERED RESOLVED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991347 ↗