TOTAL PROTEIN
Received Jun 28, 2011 · Event occurred Jun 14, 2011
Report 1823260-2011-03499 · MDR key 2143257
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
12000903216
Lot number
63476401
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED A QUESTIONABLE TOTAL PROTEIN RESULT FOR ONE PATIENT SAMPLE FROM THE ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT FROM AN ALIQUOT OF THE SAMPLE WAS 11.8 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 6.6 G/DL. THE ALIQUOT WAS THEN REPEATED AND THE RESULT WAS 6.6 G/DL. THE REPORTED RESULT WAS CORRECTED ON (B)(6) 2011. THE USER DID NOT HAVE ACCESS TO INFORMATION CONCERNING IF THE PATIENT WAS ADVERSELY AFFECTED. THE TOTAL PROTEIN R2 REAGENT LOT NUMBER WAS 63554801. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED MULTIPLE AREAS OF THE ANALYZER AND ALL WERE ACCEPTABLE. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING ON THE TOTAL PROTEIN ASSAY.