ALBUMIN BCG METHOD
Received Jun 29, 2011 · Event occurred Jun 16, 2011
Report 1823260-2011-03505 · MDR key 2143296
Device
Generic name
Bromcresol Green Dye-binding, Albumin
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11929640216
Lot number
63632101
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED QUESTIONABLE ALBUMIN RESULTS FROM THE ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) THAT WERE DISCOVERED WHEN THEY WERE COMPARED TO THE PATIENT'S PREVIOUS RESULTS. THE USER STATED THEY HAD TO CORRECT RESULTS FOR ABOUT 20 PATIENT SAMPLES. HOWEVER, SPECIFIC DATA WAS PROVIDED FOR ONLY ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.1 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 3.5 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE ALBUMIN R2 REAGENT LOT NUMBER WAS 63700201. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE FOUND A PARTIALLY CLOTTED SAMPLE PROBE AND STYLETTED ALL FOUR SAMPLE PROBES. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED PRECISION CHECKS WITH ALL RESULTS WITHIN SPECIFICATIONS.