PHOSPHATE (INORGANIC) VER.2
Received Jul 12, 2022 · Event occurred Jun 19, 2022
Report 1823260-2022-02049 · MDR key 14984854
Device
Generic name
Phosphomolybdate (colorimetric) - Inorganic Phosphorous
Manufacturer
Roche DiagnosticsModel number
PHOS2Catalog number
08058610190
Lot number
57951801
Product problems
- Low Test Results
- Low Test Results
Patient
46 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NA.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 PHOSPHATE (INORGANIC) VER.2 ON A COBAS C 503 ANALYTICAL UNIT (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PHOSPHORUS VALUE OF 2.69 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS REPEATED, RESULTING IN A PHOSPHORUS VALUE OF 2.68 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING IN A PHOSPHORUS VALUE OF 2.33 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AGAIN AT DECREASED SAMPLE VOLUME, RESULTING IN A PHOSPHORUS VALUE OF 2.55 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING ATYPICAL KINETIC BEHAVIOR. THE SAMPLE WAS THEN REPEATED ON A SECOND ANALYZER AT DECREASED SAMPLE VOLUME, RESULTING IN A PHOSPHORUS VALUE OF 3.54 MG/DL. THIS VALUE WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE CUSTOMER STATED THE PATIENT SAMPLE WAS ICTERIC UPON VISUAL CHECK. THE ISSUE WAS RESOLVED BY RE-DRAWING THE PATIENT. THE INVESTIGATION DETERMINED THE CUSTOMER ACTIONS RESOLVED THE ISSUE.