PHOSPHATE (INORGANIC) VER.2
Received Nov 10, 2025 · Event occurred Oct 21, 2025
Report 1823260-2025-04571 · MDR key 23512424
Device
Generic name
Phosphomolybdate (colorimetric) - Inorganic Phosphorous
Manufacturer
Roche DiagnosticsCatalog number
08058610190
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 QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FOR 5 PATIENT SAMPLES ON A COBAS C 703 ANALYTICAL UNIT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED. FOR SAMPLE 1, THE INITIAL RESULT WAS 9.5 MG/DL. THE REPEAT RESULT WAS 5.4 MG/DL. FOR SAMPLE 2, THE INITIAL RESULT WAS APPROXIMATELY 8 MG/DL. THE REPEAT RESULT WAS 2 MG/DL.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE COBAS C 703 ANALYTICAL UNIT OR A SIMILAR DEVICE IS NOT CLEARED OR APPROVED FOR USE IN THE US. THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE PROBES WERE MISALIGNED/OUT OF ADJUSTMENT AT THE WASH STATION. HE RE-ALIGNED AND RECALIBRATED THE SAMPLE PROBE WASHING AND DRYING POSITIONS. HE ALSO RE-ALIGNED THE REAGENT PROBES (DISK A) AND VERIFIED THE CORRECT FUNCTIONING OF OTHER INSTRUMENT COMPONENTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.