PHOSPHATE (INORGANIC) VER.2
Received Oct 28, 2025 · Event occurred Oct 6, 2025
Report 1823260-2025-04387 · MDR key 23406389
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Roche DiagnosticsCatalog number
03183793122
Lot number
ASKU
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
THERE WAS AN ALLEGATION OF A QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 8.7 MG/DL. THE REPEAT RESULT MEASURED ON A DIFFERENT C501 MODULE WAS 3.9 MG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE DOCTOR AS IT DID NOT ALIGN WITH THE PATIENT¿S CLINICAL CONDITION.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT CASSETTE. FOLLOWING THE FSE INTERVENTION, NO FURTHER ISSUE WAS OBSERVED. THE INVESTIGATION DETERMINED THE ROOT CAUSE IS LIKELY A SINGLE DENATURED CASSETTE. A REAGENT CASSETTE CAN BE DENATURED DUE TO A STORAGE OR TRANSPORT ISSUE, A HANDLING ISSUE, CARRYOVER, OR A CONTAMINATION ISSUE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.