COBAS C 503 ANALYTICAL UNIT

Report

Report Number: 1823260-2025-04067
Event Type: Malfunction
Date Received: October 6, 2025
Date of Event: August 17, 2025
Report Date: May 27, 2026
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K191899
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE CREP2 REAGENT LOT NUMBER WAS 863540 WITH AN EXPIRATION DATE OF 31-DEC-2025. THE ALB2 REAGENT LOT NUMBER WAS 855750 WITH AN EXPIRATION DATE OF 31-MAY-2026. THE UREAL REAGENT LOT NUMBER WAS 885731 WITH AN EXPIRATION DATE OF 31-MAR-2026. THE GLUC3 REAGENT LOT NUMBER WAS 836472 WITH AN EXPIRATION DATE OF 31-JAN-2026.

Additional Manufacturer Narrative · 0

ADDITIONAL DISCREPANT RESULTS WERE PROVIDED FOR 11 PATIENT SAMPLES (PATIENT 8 THROUGH PATIENT 18). ON (B)(6) 2025, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE ARM. ON (B)(6) 2025, PATIENT 8 INITIAL GLUC3 RESULT WAS 0.353 MMOL/L. THE REPEAT RESULT WAS 6.07 MMOL/L. ON (B)(6) 2025, THE FSE REPLACED THE GEAR PUMP HEAD AND THE WATER VALVE. ON (B)(6) 2025, THE FSE REPLACED THE CHECK VALVE AND THE SAMPLE PROBE. ON (B)(6) 2025, PATIENT 9 INITIAL CREP2 RESULT WAS 13.9 UMOL/L. THE REPEAT RESULT WAS 1110 UMOL/L. ON (B)(6) 2025, THE FSE REPLACED THE SAMPLE PROBE AND THE PRINTED CIRCUIT BOARD. ON (B)(6) 2025, PATIENT 10 INITIAL GLUC3 RESULT WAS 0.33 MMOL/L. THE REPEAT RESULT WAS 15.1 MMOL/L. ON (B)(6) 2025, PATIENT 11 INITIAL GLUC3 RESULT WAS 0.205 MMOL/L. THE REPEAT RESULT WAS 5.15 MMOL/L. ON (B)(6) 2025, PATIENT 12 INITIAL GLUC3 RESULT WAS 0.280 MMOL/L. THE REPEAT RESULT WAS 9.40 MMOL/L. ON (B)(6) 2025, PATIENT 13 INITIAL UREA RESULT WAS 2.26 MMOL/L. THE REPEAT RESULT WAS 24.5 MMOL/L. ON (B)(6) 2025, PATIENT 14 INITIAL GLUC3 RESULT WAS 0.297 MMOL/L. THE REPEAT RESULT WAS 6.50 MMOL/L. ON (B)(6) 2025, THE FSE REPLACED THE SAMPLE PROBE ARM AGAIN. ON (B)(6) 2025, PATIENT 15 INITIAL GLUC3 RESULT WAS 0.260 MMOL/L. THE REPEAT RESULT WAS 5.47 MMOL/L. ON (B)(6) 2025, PATIENT 16 INITIAL GLUC3 RESULT WAS 0.132 MMOL/L. THE REPEAT RESULT WAS 10.3 MMOL/L. ON (B)(6) 2025, PATIENT 17 INITIAL GLUC3 RESULT WAS 0.153 MMOL/L. THE REPEAT RESULT WAS 5.34 MMOL/L. ON (B)(6) 2025, PATIENT 18 INITIAL CREP2 RESULT WAS 13.8 UMOL/L. THE REPEAT RESULT WAS 148 UMOL/L. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative · 0

ADDITIONAL DISCREPANT RESULTS WERE PROVIDED FOR 24 PATIENT SAMPLES (PATIENTS 32 - 55). ON (B)(6) 2025 PATIENT 32 INITIAL GLUC3 RESULT WAS 0.216 MMOL/L. THE REPEAT RESULT WAS 7.11 MMOL/L. ON (B)(6) 2026 PATIENT 33 INITIAL TOTAL PROTEIN RESULT WAS 2.55 G/L. THE REPEAT RESULT WAS 59.6 G/L. PATIENT 34 INITIAL UREAL RESULT WAS 0.894 MMOL/L. THE REPEAT RESULT WAS 35.9 MMOL/L. ON (B)(6) 2026 PATIENT 35 INITIAL ALB2 RESULT WAS 20.1 G/L. THE REPEAT RESULT WAS 39.2 G/L. ON (B)(6) 2026 PATIENT 36 INITIAL GLUC3 RESULT WAS 0.140 MMOL/L. THE REPEAT RESULT WAS 7.30 MMOL/L. ON (B)(6) 2026 PATIENT 37 INITIAL GLUC3 RESULT WAS 0.241 MMOL/L. THE REPEAT RESULT WAS 8.60 MMOL/L. PATIENT 38 INITIAL LIPASE RESULT WAS 2.10 MMOL/L. THE REPEAT RESULT WAS 47.6 MMOL/L. PATIENT 39 INITIAL GLUC3 RESULT WAS 0.123 MMOL/L. THE REPEAT RESULT WAS 7.59 MMOL/L. ON (B)(6) 2026 PATIENT 40 INITIAL LIPASE RESULT WAS 0.840 MMOL/L. THE REPEAT RESULT WAS 27.1 MMOL/L. PATIENT 41 INITIAL GLUC3 RESULT WAS 0.334 MMOL/L. THE REPEAT RESULT WAS 6.02 MMOL/L. PATIENT 42 INITIAL TOTAL PROTEIN RESULT WAS 2.96 G/L. THE REPEAT RESULT WAS 64.2 G/L. ON (B)(6) 2026 PATIENT 43 INITIAL CREP2 RESULT WAS 14.7 UMOL/L. THE REPEAT RESULT WAS 508 UMOL/L. ON (B)(6) 2026 PATIENT 44 INITIAL TOTAL PROTEIN RESULT WAS 2.42 G/L. THE REPEAT RESULT WAS 73.9 G/L. ON (B)(6) 2026 PATIENT 45 INITIAL UREAL RESULT WAS 0.947 MMOL/L. THE REPEAT RESULT WAS 22.5 MMOL/L. PATIENT 46 INITIAL TOTAL PROTEIN RESULT WAS 3.89 G/L. THE REPEAT RESULT WAS 74.1 G/L. ON (B)(6) 2026 PATIENT 47 INITIAL CHOLESTEROL RESULT WAS 0.478 MMOL/L. THE REPEAT RESULT WAS 2.67 MMOL/L. ON (B)(6) 2026 PATIENT 48 INITIAL ALB2 RESULT WAS 5.36 G/L. THE REPEAT RESULT WAS 39.0 G/L. ON (B)(6) 2026 PATIENT 49 INITIAL CREP2 RESULT WAS 8.95 UMOL/L. THE REPEAT RESULT WAS 238 UMOL/L. PATIENT 50 INITIAL GLUC3 RESULT WAS 0.218 MMOL/L. THE REPEAT RESULT WAS 5.14 MMOL/L. ON (B)(6) 2026 PATIENT 51 INITIAL GLUC3 RESULT WAS 0.171 MMOL/L. THE REPEAT RESULT WAS 5.31 MMOL/L. PATIENT 52 INITIAL GLUC3 RESULT WAS 0.213 MMOL/L. THE REPEAT RESULT WAS 12.7 MMOL/L. PATIENT 53 INITIAL ALB2 RESULT WAS 3.82 G/L. THE REPEAT RESULT WAS 41.6 G/L. ON (B)(6) 2026 PATIENT 54 INITIAL GLUC3 RESULT WAS 0.605 MMOL/L. THE REPEAT RESULT WAS 18.8 MMOL/L. PATIENT 55 INITIAL GLUC3 RESULT WAS 0.226 MMOL/L. THE REPEAT RESULT WAS 6.10 MMOL/L. THE LIPASE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CHOLESTEROL REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

Additional Manufacturer Narrative · 0

REAGENT ISSUES WERE EXCLUDED AS THE CORRECT REPEAT RESULT WAS RECEIVED USING THE SAME REAGENT. THE INVESTIGATION INCLUDED AN ON-SITE VISIT TO THE CUSTOMER'S LABORATORY. AN UNUSUALLY HIGH NUMBER OF UNDER-FILLED TUBES WERE OBSERVED ARRIVING AT THE LABORATORY FOR ANALYSIS. THESE TUBES ARE PRESORTED BY THE CUSTOMER AND MANUALLY PREPARED RATHER THAN LOADED ONTO THE COBAS 8100 INSTRUMENT FOR SAMPLE PROCESSING. THE MANUAL WORKFLOW FOR THESE UNDER-FILLED SAMPLES INCLUDES TWO NON-COOLED CENTRIFUGES. IF THE TEMPERATURE IS TOO HIGH, THE GEL CANNOT WORK CORRECTLY AND CAN CAUSE "GEL-POLLUTED" SAMPLE MATERIAL. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES.

Additional Manufacturer Narrative · 0

ON 12-DEC-2025, THE SAMPLE PROBE WAS REPLACED. ON 17-DEC-2025, THE CENTRIFUGATION UNIT WAS CONFIGURED TO 3200 REVOLUTIONS PER MINUTE FOR 600 SECONDS. ON 22-DEC-2025, THE SAMPLE PROBE WAS REPLACED, AND ALL RINSE TUBING FUNCTIONALITY WAS CHECKED. ON 23-DEC-2025 THE SAMPLE PROBE WAS REPLACED, AND THE TUBE HEIGHT RECOGNITION READER WAS CLEANED. ON 24-DEC-2025, THE DEGASSER PUMP WAS REPLACED. ON 04-JAN-2026, THE VACUUM PUMP, RINSE TUBING, WASTE VALVE, AND CELL RINSE VALVE WERE REPLACED. THE WATER PRESSURE WAS OPTIMIZED, THE CELL RINSE VOLUMES WERE VERIFIED, AND THE GEAR PUMP PRESSURE WAS ADJUSTED. ADDITIONAL DISCREPANT RESULTS WERE PROVIDED FOR 7 PATIENT SAMPLES (PATIENTS 25 - 31). ON (B)(6) 2026, PATIENT 25 INITIAL GLUC3 RESULT WAS 0.176 MMOL/L. THE REPEAT RESULT WAS 19.8 MMOL/L. PATIENT 26 INITIAL UREAL RESULT WAS 0.529 MMOL/L. THE REPEAT RESULT WAS 25.5 MMOL/L. PATIENT 27 INITIAL GLUC3 RESULT WAS 0.317 MMOL/L. THE REPEAT RESULT WAS 6.57 MMOL/L. PATIENT 28 INITIAL GLUC3 RESULT WAS 0.620 MMOL/L. THE REPEAT RESULT WAS 14.4 MMOL/L. ON (B)(6) 2026, PRECISION TESTING WAS PERFORMED USING QUALITY CONTROL MATERIAL. THE RESULTS FOR ONE ASSAY OF 8 WERE OUTSIDE OF SPECIFICATION. THE REACTION CELLS WERE REPLACED. ON (B)(6) 2026, PATIENT 29 INITIAL TOTAL PROTEIN RESULT WAS 2.97 G/L. THE REPEAT RESULT WAS 68.4 G/L. ON (B)(6) 2026 PATIENT 30 INITIAL CREP2 RESULT WAS 8.12 UMOL/L. THE REPEAT RESULT WAS 135 UMOL/L. PATIENT 31 INITIAL UREAL RESULT WAS 0.980 MMOL/L. THE REPEAT RESULT WAS 17.3 MMOL/L. ON 14-JAN-2026, THE WATER RESERVOIR WAS CLEANED. ON 15-JAN-2026, PREVENTIVE MAINTENANCE WAS COMPLETED ON THE CUSTOMER'S WATER SYSTEM. ON 15-JAN-2026 THE FIELD SERVICE ENGINEER (FSE) REPLACED ONE SAMPLE PROBE AND THE SYRINGE SEAL PIECES FROM THE 2ND SAMPLE PROBE. THE ALIGNMENT FOR SAMPLE PROBE 2 WAS CHECKED, AND COATING WAS OBSERVED. SAMPLE PROBE 2 WAS ALSO REPLACED. THE TOTAL PROTEIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative · 0

THE FIELD SERVICE ENGINEER (FSE) FOUND A CLIP WAS MISSING FROM A RINSE NOZZLE AND INSTALLED A NEW ONE. THE FSE REPLACED THE SAMPLE SYRINGE, THE SAMPLE PROBE, AND THE RINSE TUBING. THE SAMPLE PROBE AND RINSE VOLUMES WERE ADJUSTED. THE REACTION CELLS AND A REAGENT PROBE WERE REPLACED. ADDITIONAL DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES (PATIENT 6 AND PATIENT 7). ON (B)(6) 2025 PATIENT 6 INITIAL (B)(6) RESULT WAS 0.151 MMOL/L. THE REPEAT RESULT WAS 5.78 MMOL/L. ON (B)(6) 2025 PATIENT 7 INITIAL (B)(6) RESULT WAS 8.76 UMOL/L. THE REPEAT RESULT WAS 108 UMOL/L. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative · 0

ADDITIONAL DISCREPANT RESULTS WERE PROVIDED FOR 6 PATIENT SAMPLES (PATIENTS 19 - 24). ON (B)(6) 2025, INSTRUMENT CHECKS WERE PERFORMED, AND THE RINSE VOLUME WAS OPTIMIZED. ON (B)(6) 2025, PATIENT 19 INITIAL CREP2 RESULT WAS 3.54 UMOL/L. THE REPEAT RESULT WAS 84.1 UMOL/L. ON (B)(6) 2025, INSTRUMENT CHECKS WERE PERFORMED, AND THE VACUUM PATH WAS CLEANED. A DROPLET WAS OBSERVED ON A NOZZLE, AND VALVES WERE REPLACED. RINSE VOLUMES WERE VERIFIED, AND NO OVERFLOW OR SPLASHING OCCURRED. ON (B)(6) 2025, INSTRUMENT CHECKS WERE PERFORMED, AND THE MIXING CHAMBER WAS REPLACED. ON (B)(6) 2025, PATIENT 20 INITIAL CREP2 RESULT WAS 28.3 UMOL/L. THE REPEAT RESULT WAS 413 UMOL/L. ON (B)(6) 2025, PATIENT 21 INITIAL GLUC3 RESULT WAS 0.132 MMOL/L. THE REPEAT RESULT WAS 7.32 MMOL/L. PATIENT 22 INITIAL GLUC3 RESULT WAS 0.13 MMOL/L. THE REPEAT RESULT WAS 9.34 MMOL/L. ON (B)(6) 2025, PATIENT 23 INITIAL GLUC3 RESULT WAS 0.164 MMOL/L. THE REPEAT RESULT WAS 5.21 MMOL/L. ON (B)(6) 2025, PATIENT 24 INITIAL GLUC3 RESULT WAS 0.6 MMOL/L. THE REPEAT RESULT WAS 11.7 MML/L. THE INVESTIGATION IS ONGOING.

Description of Event or Problem · 0

THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE IDENTIFIED FOR 5 PATIENT SAMPLES TESTED FOR CREATININE PLUS VER.2 (CREP2), ALBUMIN GEN.2 (ALB2), UREA/BUN (UREAL), AND GLUCOSE HK GEN.3 (GLUC3). PATIENT 1 INITIAL ALB2 RESULT WAS 2.41 G/L. THE REPEAT RESULT WAS 35.0 G/L. ON (B)(6) 2025 PATIENT 2 INITIAL CREP2 RESULT WAS 12.7 UMOL/L. THE REPEAT RESULT WAS 273 UMOL/L. PATIENT 3 INITIAL UREAL RESULT WAS 0.634 MMOL/L. THE REPEAT RESULT WAS 13.5 MMOL/L. ON (B)(6) 2025 PATIENT 4 INITIAL CREP2 RESULT WAS 161 UMOL/L. THE REPEAT RESULT WAS 89.3 UMOL/L. ON (B)(6) 2025 PATIENT 5 INITIAL GLUC3 RESULT WAS 0.280 MMOL/L. THE REPEAT RESULT WAS 2.38 MMOL/L.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
608946	COBAS C 503 ANALYTICAL UNIT	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1