TOTAL PROTEIN URINE/CSF GEN.3
Received Oct 9, 2025 · Event occurred Sep 16, 2025
Report 1823260-2025-04125 · MDR key 23256138
Device
Generic name
Turbidimetric, Total Protein
Manufacturer
Roche DiagnosticsCatalog number
03333825190
Lot number
86777201
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 68 MG/DL. THE REPEAT RESULT WAS 55 MG/DL. THE REPEAT RESULT FROM A DIMENSION EXL200 (SIEMENS, FLEX CARTRIDGE URINE CEREBROSPINAL FLUID PROTEIN UCFP/PYROGALLOL RED LABORATORY METHOD) WAS 19 MG/DL. THE URINE QUALITATIVE RESULT WAS NEGATIVE. THE REPORTER STATED THAT THE PATIENT IS MEDICATED WITH PLAQUENIL (ACTIVE INGREDIENT: HYDROXYCHLOROQUINE SULFATE) AND WOULD LIKE TO KNOW IF THIS DRUG INTERFERES WITH THE ASSAY.
Additional Manufacturer Narrative
THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE ALARM TRACE SHOWED "ABNORMAL PROBE SUCKING" ALARMS. A PRE-ANALYTICAL HANDLING ISSUE COULD NOT BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.