TOTAL PROTEIN URINE/CSF GEN.3
Received Oct 6, 2025 · Event occurred Sep 12, 2025
Report 1823260-2025-04075 · MDR key 23223927
Device
Generic name
Urine/csf Total Protein Test
Manufacturer
Roche DiagnosticsCatalog number
08058679190
Lot number
852901
Product problems
- False Positive Result
- Incorrect Measurement
- False Positive Result
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS A NEGATIVE PROTEIN RESULT WAS EXPECTED. THE INITIAL RESULT WAS 93.8 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER IN ANOTHER LABORATORY AND THE RESULT WAS 93.8 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON A U601 ANALYZER AND THE RESULT WAS NEGATIVE.
Additional Manufacturer Narrative
SECTION A2 AND A3 WERE UPDATED, AS WELL AS PATIENT MEDICATIONS. CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH A PATIENT SAMPLE ISSUE.