TOTAL PROTEIN URINE/CSF GEN.3
Received Jun 5, 2026 · Event occurred May 12, 2026
Report 1823260-2026-02226 · MDR key 25409772
Device
Generic name
Urine/csf Total Protein Test
Manufacturer
Roche DiagnosticsCatalog number
08058679190
Lot number
94146701
Product problems
- High Test Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6) THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR ONE CEREBROSPINAL FLUID (CSF) PATIENT SAMPLE TESTED ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT, PERFORMED IN NORMAL VOLUME MODE, WAS AN INVALIDATING DATA FLAG. THE REPEAT RESULT PERFORMED IN DECREASED VOLUME MODE WAS 6.00 G/L WITH AN INVALIDATING DATA FLAG. THIS RESULT WAS QUESTIONED BECAUSE THE CSF WAS CLEAR, WITHOUT RED OR WHITE BLOOD CELLS, AND THE GLUCOSE WAS NORMAL (NOT SUGGESTIVE OF INFECTION). THE REPEAT RESULT PERFORMED IN URINE ASSAY MODE WAS AN INVALIDATING DATA FLAG. THE REPEAT RESULT PERFORMED IN DECREASED VOLUME URINE ASSAY MODE WAS 5057 MG/L. THE CUSTOMER SUSPECTS AN INTERFERENT IN THE PATIENT SAMPLE.