Creatine Kinase 5168546190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630924974), received between Dec 8, 2023 and May 17, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE CK CREATINE KINASE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. ON (B)(6) 2024, THE INITIAL CK RESULT WAS 8238 U/L. THE SAMPLE WAS REPEATED WITH AN INCREASED DILUTION AND THE RESULT WAS 3958 U/L. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 10250 U/L. ON (B)(6) 2024, THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 8256 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345754 ↗
• InjuryDec 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED THERE WAS A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH CK ON A COBAS 8000 C702 MODULE WHICH LED TO A DELAY IN THE PATIENT RECEIVING THE CORRECT DIAGNOSIS AND THE APPROPRIATE TREATMENT. THE PATIENT REPORTEDLY PRESENTED TO THE HOSPITAL WITH WHOLE-BODY ACHES, SPECIFICALLY IN THE ABDOMEN, REDUCED SENSATION AND STRENGTH IN ONE LEG, AND VOMITING. THE PATIENT REPORTEDLY FELL A FEW DAYS BEFORE ADMISSION. THE PATIENT REPORTEDLY HAD A CREATININE VALUE OF APPROXIMATELY 400 UMOL/L AND WAS ALLEGEDLY IN RENAL FAILURE AT THE TIME OF ADMISSION. THE SAMPLE WAS REPORTEDLY COLLECTED FROM THE PATIENT AT THE TIME THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE SAMPLE REPORTEDLY HAD LOW VOLUME, SO THE ANALYSIS WAS PERFORMED WITH THE SAMPLE PLACED INTO A MICRO-CUP ON TOP OF A SAMPLE TUBE. THE SAMPLE INITIALLY RESULTED IN A CK VALUE OF 414.2 U/L. THE PATIENT WAS ALLEGEDLY INCORRECTLY DIAGNOSED WITH COLD SEPSIS DUE TO THE VALUE. A SECOND SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023 RESULTED IN A CK VALUE OF 99843 U/L, SO THE LOW VALUE FROM THE FIRST SAMPLE WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON (B)(6) 2023, RESULTING IN A CK VALUE OF - 305.3 U/L

  Patient problems: Renal Failure

  MAUDE report 18304186 ↗
• MalfunctionDec 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CK ON A COBAS 8000 C702 MODULE. THE CUSTOMER ALLEGES THAT THE RESULTS MAY INDICATE THERE IS AN INTERFERENT IN THE SAMPLE THAT REACTS WITH THE ASSAY. THE SAMPLE INITIALLY RESULTED IN A CK VALUE OF 1026 IU/L ACCOMPANIED BY A DATA FLAG INDICATING THE REACTION LIMIT WAS EXCEEDED. THE SAMPLE REPEATED WITH A CK VALUE OF > 34041 IU/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED X20 AND REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN CK VALUES OF 22 IU/L AND 30 IU/L. THE SAMPLE WAS TESTED AGAIN WITHOUT DILUTION ON THE COMPLAINED ANALYZER, RESULTING IN A CK VALUE OF 30 IU/L. THE SAMPLE WAS DILUTED AGAIN USING AN UNKNOWN DILUTION FACTOR AND REPEATED ON AN UNKNOWN ANALYZER, RESULTING IN A CK VALUE OF 30 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293647 ↗