Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge 10444895Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768013898), received between Feb 16, 2018 and Mar 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED MASS CREATINE KINASE MB ISOENZYME (LMMB) WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION EXL INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS SENT TO AN ALTERNATE LABORATORY FOR TESTING ON AN ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. A CORRECTED RESULT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LMMB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361129 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  A PATIENT SAMPLE DEMONSTRATED A REPEATABLE DIFFERENCE IN LOW VOLUME MASS CREATININE KINASE (LMMB) RECOVERY WHEN TESTING SERUM AND PLASMA SAMPLES OBTAINED DURING THE SAME VENIPUNCTURE. A DISCORDANT FALSELY DEPRESSED SERUM RESULT FOR LMMB WAS OBTAINED ON THE PATIENT SERUM SAMPLE AND A HIGHER RESULT WAS OBTAINED ON THE PLASMA SAMPLE BOTH PROCESSED ON THE DIMENSION EXL INSTRUMENT. THE INITIAL SERUM AND PLASMA RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE REPEATED SERUM AND PLASMA RESULTS CORRELATED WITH THE INITIAL RESULTS. THE REPEAT TESTING ON THE ORIGINAL SERUM SAMPLE OBTAINED A LOWER RESULT THAN THE RESULT OBTAINED ON THE PLASMA SAMPLE. THE REPEAT PLASMA SAMPLE WAS REPORTED AND NOT QUESTIONED. THERE IS NO KNOWN REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED SERUM LMMB RESULT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278372 ↗