Atellica CH ECRE3 11537216Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00630414610948), received between Nov 21, 2023 and Apr 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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.

• MalfunctionApr 25, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED ENZYMATIC CREATININE_3 (ECRE3) PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. THE LOWER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). CUSTOMER STATED THAT THE PATIENT DISCHARGE WAS DELAYED DUE TO THE EVENT AND CONFIRMED THAT THERE WAS NO ADVERSE EFFECT OR IMPACT ON PATIENT CARE DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC CREATININE_3 (ECRE3) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180890 ↗
• MalfunctionApr 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY ELEVATED ENZYMATIC CREATININE_3 (ECRE3) RESULTS ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT, PROCESSED, AND THEN REPROCESSED ON AN ALTERNATE SYSTEM ON SUBSEQUENT DAYS IN ANOTHER LABORATORY. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. ONE OF THE LOWER RESULTS FROM THE ALTERNATE SYSTEM WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT THE PATIENT WAS HOSPITALIZED FOR 2 DAYS BASED ON THE ERRONEOUSLY ELEVATED ECRE3 RESULTS. NO UNNECESSARY MEDICAL PROCEDURE OR TREATMENT WAS PERFORMED ON THE PATIENT. THE PATIENT WAS UNDER OBSERVATION IN THE HOSPITAL AND WAS RELEASED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED ENZYMATIC CREATININE_3 (ECRE3) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153305 ↗
• MalfunctionDec 26, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT DUE TO OUT-OF-RANGE QUALITY CONTROL IN THE EVENING (CLOSING), FOUR HUNDRED PATIENT SAMPLES HAD TO BE REPEATED FOR THE ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3) ASSAY. THE INITIAL TESTING WAS PROCESSED ON THE ATELLICA CH 930 ANALYZER S/N (B)(6) AND THE REPEAT TESTING WAS PROCESSED ON THE SAME ATELLICA CH 930 ANALYZER AFTER A NEW CALIBRATION AND QUALITY CONTROL IN RANGE. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. A CORRECTED REPORT WAS ISSUED. PATIENT DATA WAS NOT PROVIDED FOR EVALUATION, AND IT IS UNKNOWN IF RESULTS WERE DISCORDANT. ONE EXAMPLE WAS PROVIDED SHOWING AN INITIAL RESULT WAS LOWER THAN THE REPEAT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ENZYMATIC CREATININE_3 (ECRE3) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393574 ↗
• MalfunctionNov 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED DISCORDANT ENZYMATIC CREATININE_3 (ECRE3) FOR A PATIENT SERUM SAMPLE PROCESSED ON THE ATELLICA CH 930 ANALYZER, SERIAL NUMBER (S/N) (B)(6) AND REAGENT LOT 123531. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE DISCORDANT RESULT WAS DISCOVERED WHEN THE CUSTOMER PERFORMED POST-ANALYSIS/REVIEW OF RESULTS FROM PATIENT SAMPLES WITH INITIAL LOW ECRE3 RESULTS. THE CUSTOMER RETESTED THE SAMPLES ON A DIFFERENT ANALYZER AND SAMPLE ID 1739795101 WAS FOUND TO BE DISCORDANT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECRE3 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181522 ↗
• MalfunctionNov 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED DISCORDANT ENZYMATIC CREATININE_3 (ECRE3) RESULTS FOR PATIENT SERUM SAMPLES PROCESSED ON THE ATELLICA CH 930 ANALYZER, SERIAL NUMBER (S/N) (B)(6) REAGENT LOT 123531. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE DISCORDANT RESULTS WERE DISCOVERED WHEN THE CUSTOMER PERFORMED POST-ANALYSIS/REVIEW OF RESULTS FROM PATIENT SAMPLES WITH INITIAL LOW ECRE3 RESULTS. THE CUSTOMER RETESTED THE SAMPLES ON A DIFFERENT ANALYZER AND INITIAL RESULTS FOR SAMPLE ID (B)(4) AND SAMPLE ID (B)(4) WERE FOUND TO BE DISCORDANT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ECRE3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181156 ↗