Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge 10444904Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842768013829), received between Jul 19, 2017 and Feb 8, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE NON-SIEMENS SYSTEMS. THE RESULTS OBTAINED WERE LOWER AND CONSIDERED CORRECT. THE RESULT FROM ONE NON-SIEMENS SYSTEM WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326994 ↗
• MalfunctionJan 9, 2019High Test Results; High Test Results

  DISCORDANT MASS CREATINE KINASE MB ISOENZYME (MMB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULTS WERE NOT REPORTED. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY ON AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULTS. THE PATIENT HAD BEEN SENT TO THE CUSTOMER HOSPITAL FOR EVALUATION FOR MYOCARDIAL INFARCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232397 ↗
• MalfunctionNov 27, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. A 1:3 DILUTION PERFORMED ON THE THIRD SPECIMEN OBTAINED LOWER RESULTS WHEN REPEATED; HOWEVER WAS STILL ELEVATED. THE SAMPLE WAS TESTED ON AN ALTERNATE METHODOLOGY ON A NON-SIEMENS INSTRUMENT AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER DID NOT KNOW WHAT ALTERNATE METHODOLOGY OR INSTRUMENT WAS USED WHEN THE SAMPLE WAS SENT OUT FOR TESTING. NO TREATMENT WAS PROVIDED TO THE PATIENT ON THE BASIS OF THE REPORTED DISCORDANT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061860 ↗
• MalfunctionNov 27, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS DILUTED AND TESTED ON THE FIRST SPECIMEN AND BOTH REPEATED RESULTS WERE ELEVATED. A 1:3 DILUTION PERFORMED ON THE SECOND SPECIMEN OBTAINED A LOWER RESULT; HOWEVER WAS STILL ELEVATED. THE SAMPLE WAS TESTED ON AN ALTERNATE METHODOLOGY ON A NON-SIEMENS INSTRUMENT AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER DID NOT KNOW WHAT ALTERNATE METHODOLOGY OR INSTRUMENT WAS USED WHEN THE SAMPLE WAS SENT OUT FOR TESTING. NO TREATMENT WAS PROVIDED TO THE PATIENT ON THE BASIS OF THE REPORTED DISCORDANT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061805 ↗
• MalfunctionJul 19, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE REPEATED RESULT >600 NG/ML WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS AUTO-DILUTED AND ELEVATED RESULTS WERE OBTAINED. MANUAL DILUTION OF THE SAMPLE (2X AND 5X) OBTAINED LOWER RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724346 ↗