Lipase colorimetric 7041918190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630934812), received between Mar 21, 2022 and Sep 8, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672516 ↗
• MalfunctionFeb 3, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LIPASE (LIPC) RESULT FOR ONE PATIENT FROM THE COBAS 8000 C702 MODULE THAT WAS BELIEVED TO BE NOT PLAUSIBLE. THE RESULT WAS 146 U/L. THE RESPONSIBLE DOCTOR BELIEVED THE RESULT DID NOT MEET THE CLINICAL SITUATION OF THE CHILD-PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292827 ↗
• MalfunctionNov 11, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE (LIPC) RESULTS FOR 1 PATIENT ON A COBAS 8000 C 702 MODULE. AN INTERFERENCE WAS SUSPECTED WITH FOOD OR CANDIES. THE INITIAL RESULT WAS 471.70 U/L. ON (B)(6) 2024 A NEW SAMPLE FROM ANOTHER LABORATORY PRODUCED A RESULT OF 47 U/L. THE SAMPLE FROM (B)(6) 2024 WAS RETESTED AND THE RESULT WAS 488 U/L. A RESULT OF 410.70 U/L WAS ALSO PROVIDED FOR THE SAMPLE FROM (B)(6) 2024. IT IS UNKNOWN WHEN THIS RESULT WAS OBTAINED, BEFORE OR AFTER THE REPEATED RESULT OF 488 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657482 ↗
• MalfunctionJul 1, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LIPC LIPASE COLORIMETRIC (LIPC) RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE. THE REPORTER SUSPECTS DRUG INTERFERENCE IN THE FIRST SAMPLE. ON (B)(6) 2024: THE INITIAL RESULT OF THE FIRST SAMPLE WAS 867 U/L. THE FIRST REPEAT RESULT OF THE FIRST SAMPLE WAS 901 U/L. THE SECOND REPEAT RESULT OF THE FIRST SAMPLE WAS >732.2 U/L. ON (B)(6) 2024: THE RESULT OF THE SECOND SAMPLE WAS 38 U/L. ON (B)(6) 2024: THE INITIAL RESULT OF THE THIRD SAMPLE WAS 89 U/L. THE FIRST REPEAT RESULT OF THE THIRD SAMPLE WAS 95 U/L. THE SECOND REPEAT RESULT OF THE THIRD SAMPLE WAS 84 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642459 ↗
• MalfunctionJun 21, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LIPC LIPASE COLORIMETRIC (LIPC) RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE. THE REPORTER SUSPECTS DRUG INTERFERENCE. ON (B)(6) 2024: AT 7:00 AM, THE PATIENT TOOK THE FOLLOWING ORAL MEDICATIONS: KESTIN - 1 TEASPOON; BILASKA 1 TEASPOON; SELEXID - 2 TABLETS; ULTRA YEAST - 1 CAPSULE; ST. JOHN'S WORT -1 TEASPOON; SANTAROM - 1 TEASPOON; AND GYNDELTA - 1 CAPSULE. AT 7:50 AM, THE PATIENT'S FIRST BLOOD SAMPLE WAS COLLECTED. THE INITIAL RESULT OF THE FIRST SAMPLE FROM THE MODULE WAS >666.40 U/L. THE REPEAT RESULT OF THE FIRST SAMPLE FROM THE MODULE WAS 831 U/L WITH A DATA FLAG. THE FIRST SAMPLE WAS RERUN ON TWO OTHER COBAS C702S AND THE RESULTS WERE STILL CLOSE TO 800 U/L. ON (B)(6) 2024: THE PATIENT DID NOT TAKE ANY MEDICATIONS. THE INITIAL RESULT OF THE SECOND SAMPLE FROM THE MODULE WAS 34 U/L. THE REPEAT RESULT OF THE SECOND SAMPLE FROM THE MODULE WAS 35 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587691 ↗
• MalfunctionAug 24, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LIPC LIPASE COLORIMETRIC (LIPC) ON A COBAS 8000 C (701) MODULE. DATA WAS PROVIDED WITH DISCREPANT RESULTS FOR AN ADDITIONAL PATIENT SAMPLE (PATIENT 2). ON (B)(6) 2023 PATIENT 2 INITIAL RESULT WAS GREATER THAN 410.6 U/L. THE REPEAT RESULT USING DILUTION WAS 478 U/L. ON (B)(6) 2023 THE REPEAT RESULT WAS 37 U/L. ON (B)(6) 2023 PATIENT 1 INITIAL RESULT WAS 700 U/L. THE SAMPLE WAS REPEATED ON (B)(6) 2023 WITH A RESULT OF 40 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613940 ↗
• MalfunctionDec 19, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE LIPC (LIPASE COLORIMETRIC) ASSAY ON TWO COBAS 8000 C702 MODULES (SERIAL NUMBERS (B)(4). THE RESULTS OF THE SAMPLE DID NOT AGREE WITH OTHER CLINICAL FINDINGS OF THE PATIENT. ON (B)(6) 2022, THE SAMPLE WAS INITIALLY TESTED ON C702 SERIAL NUMBER (B)(4), RESULTING IN AN LIPC VALUE OF 738.4 U/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH A REDUCED VOLUME, RESULTING IN AN LIPC VALUE OF 900.3 U/L. BASED ON THIS RESULT, THE PATIENT WAS HOSPITALIZED AGAIN. ON (B)(6) 2022, A SAMPLE OF THE PATIENT WAS TESTED IN THE HOSPITAL WITH AN UNKNOWN METHOD, RESULTING IN A LIPASE VALUE OF 97. NO UNIT OF MEASURE WAS PROVIDED. ON (B)(6) 2022, THE SAMPLE FROM (B)(6) 2022 WAS REPEATED ON C702 SERIAL NUMBER (B)(4), RESULTING IN AN LIPC VALUE OF 758.4 U/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH A REDUCED VOLUME, RESULTING IN AN LIPC VALUE OF 927.8 U/L. THE RESULT OF (B)(6) 2022 WAS DEEMED TO BE "TOO HIGH" AND CLINICALLY NOT POSSIBLE. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003761 ↗
• MalfunctionOct 29, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT TESTED WITH LIPC (LIPASE COLORIMETRIC) ON A COBAS 8000 C702 MODULE WITH SERIAL NO. 1944-10. THE RESULTS MEASURED ON THE C702 MODULE DID NOT COMPARE TO THE RESULTS OBTAINED WITH THE BECKMAN COULTER METHOD AND TO THE EXPECTED VALUES BASED ON THE CLINICAL HISTORY OF THE PATIENT. ON (B)(6) 2022, THE INITIAL SAMPLE, COLLECTED AT 6.15 AM RESULTED IN A VALUE OF 558 U/L. ON (B)(6) 2022, A SECOND SAMPLE FROM THE SAME PATIENT, COLLECTED AT 12 AM RESULTED IN A VALUE OF 77 U/L, TESTED WITH THE BECKMAN COULTER METHOD. ON (B)(6) 2022, A THIRD SAMPLE FROM THE SAME PATIENT, COLLECTED AT 9.20 AM RESULTED IN A VALUE OF 362 U/L. ON (B)(6) 2022, A FOURTH SAMPLE FROM THE SAME PATIENT, COLLECTED AT 12:04 PM RESULTED IN A VALUE OF 110 U/L, TESTED WITH THE BECKMAN COULTER METHOD. ON (B)(6) 2022, A FIFTH SAMPLE FROM THE SAME PATIENT, COLLECTED AT 5.20 PM ON (B)(6) 2022 RESULTED IN A VALUE OF 92.4 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696413 ↗
• MalfunctionMay 7, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE LIPC LIPASE COLORIMETRIC ASSAY ON TWO COBAS 8000 C (701) MODULES (SERIAL NUMBERS (B)(4)). THE RESULTS OF THE SAMPLE DID NOT AGREE WITH OTHER CLINICAL FINDINGS OF THE PATIENT. THE COMPLAINED SAMPLE WAS INITIALLY TESTED ON C701 SERIAL NUMBER (B)(4), RESULTING IN A LIPASE VALUE OF 239 U/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER DUE TO AN INTERNAL LABORATORY RULE, RESULTING IN A VALUE OF 239 U/L. THE VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS PRESCRIBED A COMPUTED TOMOGRAPHY SCAN BASED ON THE HIGH VALUE AND A SECOND SAMPLE COLLECTION WAS REQUESTED. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED TWICE ON C701 SERIAL NUMBER (B)(4) ON (B)(6) 2022, RESULTING IN LIPASE VALUES OF 37 U/L AND 36 U/L. BOTH THE COMPLAINED SAMPLE AND SECOND SAMPLE WERE REPEATED. THE COMPLAINED SAMPLE WAS REPEATED ON C701 SERIAL NUMBER (B)(4), RESULTING IN A LIPASE VALUE OF 220 U/L. THE SECOND SAMPLE WAS REPEATED ON C701 SERIAL NUMBER (B)(4), RESULTING IN A VALUE OF 37 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14321900 ↗
• MalfunctionMar 21, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LIPC LIPASE COLORIMETRIC ASSAY RESULTS FOR ONE PATIENT TESTED ON TWO COBAS 8000 C (701) MODULES. IT WAS UNKNOWN WHICH COBAS 8000 C (701) MODULE WAS USED FOR EACH LIPASE RESULT. THE CUSTOMER PROVIDED THE SERIAL NUMBER OF ONE COBAS 8000 C (701) MODULE, 19R1-07. ON 24-FEB-2022, THE PATIENT'S INITIAL LIPASE RESULT WAS 202 U/L. DUE TO AN INTERNAL LABORATORY RULE, THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE PATIENT'S LIPASE RESULT WAS 201 U/L. THE CUSTOMER REPORTED ONE OF THE PATIENT'S LIPASE RESULTS OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN DIDN'T TRUST THE REPORTED LIPASE RESULTS AND REQUESTED A NEW SAMPLE TO BE TESTED. ON 25-FEB-2022, THE PATIENT WENT TO A DIFFERENT LABORATORY AND HAD A NEW SAMPLE COLLECTED. THE PATIENT'S NEW SAMPLE HAD A LIPASE RESULT OF 36 U/L ON AN UNKNOWN METHODOLOGY. THE PATIENT QUESTIONED THE LIPASE RESULTS BETWEEN THE TWO LABORATORIES. ON 26-FEB-2022, THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S INITIAL SAMPLE ON BOTH COBAS 8000 C (701) MODULES AND HAD A LIPASE RESULT OF 203 U/L. THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED ON THE INITIAL COBAS 8000 C (701) MODULE, AND THE PATIENT'S LIPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838947 ↗