GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 00044345010Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08426951070800), received between Mar 12, 2025 and Dec 18, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025High Test Results; High Test Results

  ON (B)(6) 2025, A CUSTOMER REPORTED HIGHER THAN EXPECTED CREATININE RESULTS FROM THEIR GEM PREMIER CHEMSTAT, WITH SOME RESULTS DOCUMENTED IN THE PATIENT MEDICAL RECORD. REPEAT TESTING PERFORMED BY THE CUSTOMER ON A LABORATORY CHEMISTRY ANALYZER YIELDED LOWER CREATININE RESULTS. NO IQM (INTELLIGENT QUALITY MANAGEMENT) FLAGS OR OTHER ERRORS WERE REPORTED BY THE GEM PREMIER CHEMSTAT INSTRUMENT. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23840513 ↗
• MalfunctionSep 19, 2025High Test Results; High Test Results

  ERRONEOUS HIGH CREATININE RESULTS (ABOVE 5 MG/DL) WERE IDENTIFIED ON THREE PATIENT SAMPLES MEASURED ON GEM PREMIER CHEMSTAT ON (B)(6) 2025. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096528 ↗
• MalfunctionSep 16, 2025High Test Results; High Test Results

  AN ERRONEOUS CREATININE RESULT WAS IDENTIFIED ON A SAMPLE MEASURED ON GEM PREMIER CHEMSTAT ON 8/21/2025. THE CHEMSTAT CREATININE MEASUREMENT WAS 316 UMOL/L, AND THE LAB CREATININE RESULT WAS 166 UMOL/L. THE LAB SAMPLE WAS TAKEN WITHIN 5 MINUTES OF THE CHEMSTAT SAMPLING. THE IQM CORRECTIVE ACTION REPORTS SHOWED NO ISSUES AND DIDN'T FLAG ANY INTERFERENCES. REPEAT LAB ANALYSIS CONFIRMED SAME RESULT (166 UMOL/L). REPEAT CHEMSTAT ANALYSIS ON 8/28/2025 AND RETURNED "INCALCULABLE" RESULTS; SAMPLE FLAGGED AS EXCESSIVE CREATINE INTERFERENCE. THE CREATINE TEST HAS BEEN DISABLED ON THE CHEMSTAT PENDING FURTHER INVESTIGATION. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063844 ↗
• MalfunctionJun 6, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  FOLLOWING REPORTS OF SPURIOUS CREATININE RESULTS ON THE GEM PREMIER CHEMSTAT (SERIAL NUMBER (B)(6)) AND A FULL INSTRUMENT HEALTH CHECK BY A WERFEN ENGINEER, WERFEN APPLICATION SPECIALISTS ANALYSED 10 X PATIENT BLOOD SAMPLES AGAINST A SECOND CHEMSTAT AND FOUND THAT THE CHEMSTAT IN QUESTION IN THIS CASE (SN (B)(6)) CONSISTENTLY PRODUCED ELEVATED CREATININE RESULTS. THIS WAS A BLOOD SAMPLE COMPARISON, NO PATIENTS HAVE BEEN AFFECTED IN THIS PARTICULAR CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161314 ↗
• MalfunctionMay 22, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  A DISCREPANCY HAS BEEN IDENTIFIED IN TEST RESULTS GENERATED BY THE ANALYZER. SPECIFICALLY, A CLINICAL USER HAS QUERIED A SAMPLE, WHERE THE RESULTS APPEAR SIGNIFICANTLY HIGHER COMPARED TO CORRESPONDING RESULTS OBTAINED FROM THE BIOCHEMISTRY DEPARTMENT. UPON FURTHER REVIEW, IT HAS BEEN OBSERVED THAT THIS IS NOT AN ISOLATED INCIDENT, MULTIPLE SAMPLES WITHIN THE SAME DATASET SHOW CONSISTENTLY ELEVATED VALUES RELATIVE TO BIOCHEMISTRY RESULTS. THE ISSUE SUGGESTS A POTENTIAL CALIBRATION OR PERFORMANCE DEVIATION OF THE ANALYZER PRIOR TO ITS WITHDRAWAL FROM SERVICE. ANALYZER WAS THEN OUT OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075156 ↗
• MalfunctionApr 2, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  CUSTOMER REPORTED DISCREPANT CREATININE RESULTS ON THE GEM PREMIER CHEMSTAT PAK (CARTRIDGE) IN COMPARISON TO RESULTS FROM THE LAB. CUSTOMER REVIEWED THE CORRECTIVE ACTION REPORT AND NOTICED INCALCULABLE INTERFERENCE WAS DETECTED 4 TIMES AND WAS CORRECTED FOR CREATININE ON THE SAME DAY AS THE DISCREPANT RESULTS. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752210 ↗
• MalfunctionMar 26, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  CUSTOMER REPORTED THAT BETWEEN 10PM AND 3AM ON (B)(6), THE CLINICIAN EXPERIENCED A NUMBER OF ELEVATED CREATININE RESULTS ON A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) THAT DID NOT MATCH THE LAB OR PATIENT CONDITION. THE RESULTS WERE OUTSIDE OF EXPECTATION AND THEREFORE FLAGGED IMMEDIATELY AS UNRELIABLE. NO ADVERSE IMPACT TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701467 ↗
• MalfunctionMar 17, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE CORRELATING HIGH COMPARED TO THEIR CORE LAB ANALYZER. RESULTS WERE RUNNING HIGH BASED ON PATIENTS' CLINICAL DIAGNOSIS AND EXCEEDING CRITERIA: 10% OR .004. CUSTOMER RESULTS WERE REPORTED. NO FURTHER PATIENT IMPACT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21622830 ↗
• MalfunctionMar 17, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE CORRELATING HIGH COMPARED TO THEIR CORE LAB ANALYZER. RESULTS WERE RUNNING HIGH BASED ON PATIENTS' CLINICAL DIAGNOSIS AND EXCEEDING CRITERIA: 10% OR .004. CUSTOMER RESULTS WERE REPORTED. NO FURTHER PATIENT IMPACT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21622612 ↗
• MalfunctionMar 17, 2025High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE RUNNING HIGH BASED ON PATIENTS' CLINICAL DIAGNOSIS. RESULTS WERE ALSO CORRELATING HIGH COMPARED TO THEIR CORE LAB ANALYZER. CUSTOMER RESULTS WERE REPORTED. NO FURTHER PATIENT IMPACT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21621740 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE READING HIGH WHEN COMPARED TO THE LABORATORY METHOD (ABBOT ALINITY CREATININE ENZYMATIC ASSAY) AFTER RUNNING A SAMPLE FROM A PATIENT ON PARACETAMOL. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590088 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE ERRONEOUSLY HIGH FOR MULTIPLE PATIENT SAMPLES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589923 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) RESULTED IN MULTIPLE HIGH CREATININE READINGS. THE SAME SAMPLE TUBES RESULTED IN NORMAL CREATINE READINGS WITH ISTAT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589707 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE IMPLAUSIBLY HIGH FOR FIVE PATIENT SAMPLES COMPARED TO RESULTS ON A DIFFERENT GEM PREMIER CHEMSTAT SYSTEM, AS WELL AS TO THEIR LABORATORY METHODS (JAFFE AND ENZYMATIC CREATININE ASSAYS). NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589202 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE SIGNIFICANTLY HIGHER THAN THE LABORATORY RESULTS (INFORMATION ON OTHER METHOD NOT PROVIDED BY CUSTOMER). NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587689 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE SIGNIFICANTLY HIGHER THAN THE LABORATORY RESULTS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587624 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE HIGHER THAN EXPECTED. WHEN THE SAME PATIENT SAMPLES WERE TESTED USING AN ISTAT SYSTEM, THE CREATININE RESULTS WERE WITHIN NORMAL RANGE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587551 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT A CREATININE RESULT FROM A GEM PREMIER CHEMSTAT PAK CARTRIDGE WAS HIGHER (1.48 MG/DL) COMPARED TO THE RESULT FROM ANOTHER METHOD (0.94 MG/DL) FOR THE SAME PATIENT SAMPLE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586584 ↗
• MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE HIGHER COMPARED TO RESULTS FROM OTHER METHODS (INFORMATION ON OTHER METHODS NOT PROVIDED BY CUSTOMER). NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586305 ↗