TOTAL PROTEIN GEN.2
Received Dec 9, 2019 · Event occurred Nov 16, 2019
Report 1823260-2019-04320 · MDR key 9436771
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03183734190
Lot number
426862
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TP2 TOTAL PROTEIN GEN.2 ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER SUSPECTS LIPEMIA MAY HAVE AFFECTED THE RESULT, BUT THE MEASURED LIPEMIA INDEX OF THE SAMPLE WAS BELOW THE INDEX LEVEL WHICH IS DOCUMENTED IN PRODUCT LABELING AS INTERFERING WITH THE ASSAY. THE SAMPLE INITIALLY RESULTED WITH A TOTAL PROTEIN VALUE OF 11.1 G/L. THE SAMPLE WAS REPEATED, RESULTING WITH A VALUE OF 26.5 G/L. THE SAMPLE WAS REPEATED AFTER HIGH SPEED CENTRIFUGATION, RESULTING WITH A VALUE OF 60 G/L. THE C 501 ANALYZER SERIAL NUMBER IS (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.