CREATININE
Report
- Report Number
- 3002809144-2024-00097
- Event Type
- Injury
- Date Received
- April 8, 2024
- Date of Event
- March 14, 2024
- Report Date
- June 12, 2024
- Manufacturer
- ABBOTT GMBH
- Product Code
- CGX
- UDI-DI
- 00380740161569
- PMA / PMN Number
- K083809
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A TICKET SEARCH BY THE LOT NUMBER 01166UN22 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE ISSUE UNDER REVIEW. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 01166UN22, WHICH DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED TO THE ISSUE UNDER REVIEW. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. THE SAMPLE WAS RETESTED WITH THE SAME REAGENT LOT NUMBER AND GAVE AN ACCEPTABLE RESULT. REVIEW OF PRODUCT LABELING FOUND ADEQUATE INFORMATION REGARDING THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CREATININE REAGENT WAS IDENTIFIED.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.
THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE RESULTS FOR A 70-YEAR-OLD MALE ADMITTED TO THE HOSPITAL FOR TREATMENT OF RENAL INSUFFICIENCY. THE CLINICAL DIAGNOSIS WAS CHRONIC KIDNEY DISEASE STAGE III WITH HYPERKALEMIA. THE INITIAL CREATINE RESULT ON (B)(6) 2024 WAS 99.7 UMOL/L (REFERENCE RANGE: 57-110), POTASSIUM RESULT ON (B)(6) 2024 WAS 3.96 MMOL/L (NORMAL RANGE 3.5-5.3), AND THE DIALYSIS TREATMENT WAS CONSIDERED TO BE EFFECTIVE. THE PATIENT WAS RECOMMENDED FOR DISCHARGE AFTER SEVERAL DAYS OF OBSERVATION. UPON DISCHARGE, A NEW BLOOD SAMPLE WAS TAKEN TO TEST FOR CREATININE, AND THE CREATININE RESULT ON (B)(6) 2024 WAS 199 UMOL/L, POTASSIUM RESULT WAS ON (B)(6) 2024 WAS 3.79 MMOL/L. THE USER RETESTED THE SAMPLE FROM (B)(6) 2024 AND THE REPEAT CREATINE RESULT WAS 190 UMOL/L. THE CLINICAL PHYSICIAN THOUGHT THAT ABBOTT¿S CREATININE RESULT CAUSED DELAYS TO THE PATIENT¿S DIALYSIS TREATMENT. UPDATE: NEW INFORMATION WAS RECEIVED ON 23APR2024. THE FOLLOWING PATIENT RESULTS WERE PROVIDED: (B)(6) 2024: POTASSIUM 3.96 MMOL/L, SODIUM 144.7 MMOL/L, CHLORIDE 109.4 MMOL/L, CALCIUM 2.09 MMOL/L, MAGNESIUM 0.81 MMOL/L, INORGANIC PHOSPHORUS 0.96 MMOL/L, GLUCOSE 5.95 MMOL/L, GLYCATED HEMOGLOBIN (FRUCTOSAMINE) 2.38 MMOL/L, UREA NITROGEN 11.93 MMOL/L, CREATININE 99.7 UMOL/L, EGFR (MDRD EQUATION) 66.1 ML/MIN, URIC ACID 497.7 UMOL/L, ASPARTATE TRANSAMINASE 25.2 U/L, ALANINE AMINOTRANSFERASE 29.0 U/L, AST/ALT 0.87, TOTAL PROTEIN 61.5 G/L, ALBUMIN 34.2 G/L, GLOBULIN 27 G/L, ALBUMIN/GLOBULIN RATIO 1.25, TOTAL BILIRUBIN 7.2 UMOL/L, DIRECT BILIRUBIN 2.0 UMOL/L, INDIRECT BILIRUBIN 5.2 UMOL/L, TOTAL BILE ACID 6.2 UMOL/L, ALKALINE PHOSPHATASE 35.6 U/L, GAMMA-GLUTAMYL TRANSFERASE 13.6 U/L, TRIGLYCERIDES 1.17 MMOL/L, TOTAL CHOLESTEROL 4.76 MMOL/L, (B)(6) 2024: POTASSIUM 3.79 MMOL/L, SODIUM 140.1 MMOL/L, CHLORIDE 108.2 MMOL/L, CALCIUM 2.03 MMOL/L, MAGNESIUM 0.71 MMOL/L, INORGANIC PHOSPHORUS 0.84 MMOL/L, GLUCOSE 2.03 MMOL/L, GLYCATED HEMOGLOBIN (FRUCTOSAMINE) 2.36 MMOL/L, UREA NITROGEN 14.59 MMOL/L, CREATININE 188.3 UMOL/L, EGFR (MDRD EQUATION) 30.63, URIC ACID 415.3 UMOL/L, ASPARTATE TRANSAMINASE 24.3 U/L, ALANINE AMINOTRANSFERASE 36.9 U/L, AST/ALT 0.66, TOTAL PROTEIN 57.9 G/L, ALBUMIN 32.1 G/L, GLOBULIN 25.8 G/L, ALBUMIN/GLOBULIN RATIO 1.24, TOTAL BILIRUBIN 3.7 UMOL/L, DIRECT BILIRUBIN 1.6 UMOL/L.
THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE RESULTS FOR A 70-YEAR-OLD MALE ADMITTED TO THE HOSPITAL FOR TREATMENT OF RENAL INSUFFICIENCY. THE CLINICAL DIAGNOSIS WAS CHRONIC KIDNEY DISEASE STAGE III WITH HYPERKALEMIA. THE INITIAL CREATINE RESULT ON (B)(6) 2024 WAS 99.7 UMOL/L (REFERENCE RANGE: 57-110), POTASSIUM RESULT ON (B)(6) 2024 WAS 3.96 MMOL/L (NORMAL RANGE 3.5-5.3), AND THE DIALYSIS TREATMENT WAS CONSIDERED TO BE EFFECTIVE. THE PATIENT WAS RECOMMENDED FOR DISCHARGE AFTER SEVERAL DAYS OF OBSERVATION. UPON DISCHARGE, A NEW BLOOD SAMPLE WAS TAKEN TO TEST FOR CREATININE, AND THE CREATININE RESULT ON (B)(6) 2024 WAS 199 UMOL/L, POTASSIUM RESULT WAS ON (B)(6) 2024 WAS 3.79 MMOL/L. THE USER RETESTED THE SAMPLE FROM (B)(6) 2024 AND THE REPEAT CREATINE RESULT WAS 190 UMOL/L. THE CLINICAL PHYSICIAN THOUGHT THAT ABBOTT¿S CREATININE RESULT CAUSED DELAYS TO THE PATIENT¿S DIALYSIS TREATMENT. UPDATE: NEW INFORMATION WAS RECEIVED ON 23APR2024. THE FOLLOWING PATIENT RESULTS WERE PROVIDED: (B)(6) 2024: POTASSIUM 3.96 MMOL/L, SODIUM 144.7 MMOL/L, CHLORIDE 109.4 MMOL/L, CALCIUM 2.09 MMOL/L, MAGNESIUM 0.81 MMOL/L, INORGANIC PHOSPHORUS 0.96 MMOL/L, GLUCOSE 5.95 MMOL/L, GLYCATED HEMOGLOBIN (FRUCTOSAMINE) 2.38 MMOL/L, UREA NITROGEN 11.93 MMOL/L, CREATININE 99.7 UMOL/L, EGFR (MDRD EQUATION) 66.1 ML/MIN, URIC ACID 497.7 UMOL/L, ASPARTATE TRANSAMINASE 25.2 U/L, ALANINE AMINOTRANSFERASE 29.0 U/L, AST/ALT 0.87, TOTAL PROTEIN 61.5 G/L, ALBUMIN 34.2 G/L, GLOBULIN 27 G/L, ALBUMIN/GLOBULIN RATIO 1.25, TOTAL BILIRUBIN 7.2 UMOL/L, DIRECT BILIRUBIN 2.0 UMOL/L, INDIRECT BILIRUBIN 5.2 UMOL/L, TOTAL BILE ACID 6.2 UMOL/L, ALKALINE PHOSPHATASE 35.6 U/L, GAMMA-GLUTAMYL TRANSFERASE 13.6 U/L, TRIGLYCERIDES 1.17 MMOL/L, TOTAL CHOLESTEROL 4.76 MMOL/L, (B)(6) 2024: POTASSIUM 3.79 MMOL/L, SODIUM 140.1 MMOL/L, CHLORIDE 108.2 MMOL/L, CALCIUM 2.03 MMOL/L, MAGNESIUM 0.71 MMOL/L, INORGANIC PHOSPHORUS 0.84 MMOL/L, GLUCOSE 2.03 MMOL/L, GLYCATED HEMOGLOBIN (FRUCTOSAMINE) 2.36 MMOL/L, UREA NITROGEN 14.59 MMOL/L, CREATININE 188.3 UMOL/L, EGFR (MDRD EQUATION) 30.63, URIC ACID 415.3 UMOL/L, ASPARTATE TRANSAMINASE 24.3 U/L, ALANINE AMINOTRANSFERASE 36.9 U/L, AST/ALT 0.66, TOTAL PROTEIN 57.9 G/L, ALBUMIN 32.1 G/L, GLOBULIN 25.8 G/L, ALBUMIN/GLOBULIN RATIO 1.24, TOTAL BILIRUBIN 3.7 UMOL/L, DIRECT BILIRUBIN 1.6 UMOL/L.
THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE RESULTS FOR A 70-YEAR-OLD MALE ADMITTED TO THE HOSPITAL FOR TREATMENT OF RENAL INSUFFICIENCY. THE CLINICAL DIAGNOSIS WAS CHRONIC KIDNEY DISEASE STAGE III WITH HYPERKALEMIA. THE INITIAL CREATINE RESULT ON (B)(6) 2024 WAS 99.7 UMOL/L (REFERENCE RANGE: 57-110), POTASSIUM RESULT ON (B)(6) 2024 WAS 3.96 MMOL/L (NORMAL RANGE 3.5-5.3), AND THE DIALYSIS TREATMENT WAS CONSIDERED TO BE EFFECTIVE. THE PATIENT WAS RECOMMENDED FOR DISCHARGE AFTER SEVERAL DAYS OF OBSERVATION. UPON DISCHARGE, A NEW BLOOD SAMPLE WAS TAKEN TO TEST FOR CREATININE, AND THE CREATININE RESULT ON (B)(6) 2024 WAS 199 UMOL/L, POTASSIUM RESULT WAS ON (B)(6) 2024 WAS 3.79 MMOL/L. THE USER RETESTED THE SAMPLE FROM (B)(6) 2024 AND THE REPEAT CREATINE RESULT WAS 190 UMOL/L. THE CLINICAL PHYSICIAN THOUGHT THAT ABBOTT¿S CREATININE RESULT CAUSED DELAYS TO THE PATIENT¿S DIALYSIS TREATMENT. THE CREATININE RESULT CAUSED DELAYS TO THE PATIENT¿S DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412649 | CREATININE | ALKALINE PICRATE, COLORIMETRY, CREATININE | CGX | ABBOTT GMBH | 01166UN22 | 00380740161569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Other| L | ARC C16K PRC MOD, 03L77-01, (B)(6) | ARC C16K PRC MOD, 03L77-01, (B)(6) | ARC C16K PRC MOD, 03L77-01, (B)(6) |