PHOS2
Received Jan 25, 2023 · Event occurred May 23, 2022
Report 1823260-2023-00232 · MDR key 16241679
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05171377190
Lot number
57491001
Product problems
- No Device Output
- High Test Results
- No Device Output
- High Test Results
Patient
83 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO THE LIMITED DATA, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE PHOSPHORUS GEN.2 RESULTS FOR ONE PATIENT FROM COBAS 8000 C702 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER ALLEGED INTERFERENCE IN THE SAMPLES. ON (B)(6) 2022, THE RESULT WAS 9.80 MG/DL. THE SAMPLE WAS REPEATED AND THE SAME RESULT WAS OBTAINED. ON (B)(6) 2022, THE RESULT FROM A NEW SAMPLE WAS 9.58 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.