PHOSPHATE (INORGANIC) VER.2
Received Dec 3, 2025 · Event occurred Nov 11, 2025
Report 1823260-2025-04930 · MDR key 23706931
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Roche DiagnosticsCatalog number
05171377190
Lot number
89812301
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
42 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPLACED THE REAGENT PACK. THE FIELD SERVICE ENGINEER (FSE) PERFORMED PRECISION TESTING SUCCESSFULLY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
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 PHOSPHATE (INORGANIC) VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLE AS THEIR QC SHIFTED. THE CUSTOMER RECALIBRATED AND REPEATED QC PRIOR TO REPEATING THE SAMPLE. THE INITIAL RESULT WAS 1.5 MG/DL. THE REPEAT RESULT WAS 1.0 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.