PHOSPHATE (INORGANIC) VER.2
Received May 29, 2025 · Event occurred Apr 30, 2025
Report 1823260-2025-01638 · MDR key 22104310
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Roche DiagnosticsCatalog number
03183793122
Lot number
83452301
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QC AND CALIBRATION WERE PASSING AT THE TIME OF THE EVENT. THE CUSTOMER DETERMINED THAT THE QUESTIONABLE RESULTS WERE DUE TO THE PATIENT SAMPLES. THE INVESTIGATION DETERMINED THAT THERE WAS NO PRODUCT ISSUE.
Additional Manufacturer Narrative
THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBERS ARE (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHATE (INORGANIC) VER.2 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT ON (B)(6) 2025 WAS 6.8 MG/DL. A REPEAT RESULT ON (B)(6) 2025 WAS 8.3 MG/DL. ANOTHER REPEAT RESULT AFTER A 1:2 DILUTION WAS 3 MG/DL. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 8.4 MG/DL. A REPEAT RESULT ON (B)(6) 2025 WAS 8.5 MG/DL. ANOTHER REPEAT RESULT AFTER A 1:2 DILUTION WAS 3.4 MG/DL. THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT.