ALBUMIN GEN.2
Received Feb 1, 2018 · Event occurred Jan 10, 2018
Report 1823260-2018-00290 · MDR key 7233467
Device
Generic name
Bromcresol Green Dye-binding, Albumin
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05166861190
Lot number
262685
Product problems
- Low Test Results
- Low Test Results
Patient
70 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ALB2 ALBUMIN GEN.2 RESULTS FOR MULTIPLE PATIENT SAMPLES FROM COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER PERFORMS QC EVERY FOUR HOURS AND IF THE RESULTS ARE OUT OF RANGE, THEY REPEAT PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 1.9 G/L AND THE REPEAT RESULT WAS 2.5 G/L. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER BELIEVED THE ISSUE OCCURRED WHEN THE REAGENT PACK VOLUME WAS LOW. AFTER EVALUATION OF THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE CANNOT BE IDENTIFIED.
Additional Manufacturer Narrative
THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT AND FOUND NO ISSUES. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. A GENERAL REAGENT OR HARDWARE ISSUE WAS EXCLUDED.