ELECSYS CA 19-9
Received Nov 10, 2025 · Event occurred Oct 11, 2025
Report 1823260-2025-04569 · MDR key 23512183
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193188
Lot number
82282401
Product problems
- Low Test Results
- Low Test Results
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS 6000 E601 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 12.96 U/ML. THE REPEAT RESULT ON A COBAS E601 WAS 15.00 U/ML. A RESULT ON A TELLGEN ANALYZER WAS 105.27 U/ML. THE REPEAT RESULT ON A TELLGEN ANALYZER WAS 112.64 U/ML. THE REPEAT RESULT ON A TELLGEN ANALYZER WITH PEG WAS 274.76 U/ML. THE REPEAT RESULT ON AN ABBOTT ANALYZER WAS 590.87 U/ML. A SECOND SAMPLE WAS COLLECTED ON (B)(6) 2025, AND THE RESULT WAS 12.69 U/ML. A REPEAT RESULT WITH A 1:5 DILUTION WAS 84.92 U/ML. A REPEAT RESULT WITH A 1:10 DILUTION WAS 129.2 U/ML. A RESULT ON A TELLGEN ANALYZER WAS 138.26 U/ML. A THIRD SAMPLE COLLECTED ON (B)(6) 2025 HAD A RESULT OF 12.58 U/ML. A FOURTH SAMPLE COLLECTED ON (B)(6) 2025 HAD A RESULT OF 13.12 U/ML. A FIFTH SAMPLE COLLECTED ON (B)(6) 2025 HAD A RESULT OF 8.53 U/ML. A REPEAT RESULT WITH A 1:10 DILUTION WAS 19.53 U/ML. A RESULT ON A TELLGEN ANALYZER WAS 11.97 U/ML. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY AND WAS DETECTABLE TO THE CUSTOMER BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE PATIENT HAD ELEVATED LIPID AND BLOOD GLUCOSE LEVELS. THE QC WAS IN RANGE ON THE DATE OF THE EVENT. PER PRODUCT LABELING, "SAMPLES WITH CA 19-9 CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT UNIVERSAL. THE RECOMMENDED DILUTION IS 1:10 (EITHER AUTOMATICALLY BY THE ANALYZERS OR MANUALLY). THE CONCENTRATION OF THE DILUTED SAMPLE MUST BE > 50 U/ML. THE CA 19-9 ANTIGEN TENDS TO AGGREGATE. THIS MAY LED TO NON-LINEAR DILUTION BEHAVIOR IN CERTAIN INDIVIDUAL SAMPLES." THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. A GENERAL REAGENT PROBLEM COULD BE EXCLUDED AS THE QC WAS WITHIN THE RANGE ON THE DATE OF THE EVENT.