ALBT2 TINA-QUANT ALBUMIN GEN.2
Received Jun 6, 2018 · Event occurred May 18, 2018
Report 1823260-2018-01763 · MDR key 7574374
Device
Generic name
Albumin, Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04469658190
Lot number
30049101
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
UNIQUE IDENTIFIER (UDI)#: (B)(4).
Description of Event or Problem
DURING INSTRUMENT COMPARISON TESTING, THE CUSTOMER IDENTIFIED AN INCORRECT RESULT FOR 1 PATIENT URINE SAMPLE TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 6000 C (501) MODULE THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL ALBT2 RESULT FROM AN ALIQUOT TUBE WAS 255 MG/L ON THE C501 MODULE IN QUESTION. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PERFORMED NUMEROUS COMPARISONS AND PRECISION STUDIES TO TROUBLESHOOT THE ISSUE. ON (B)(6) 2108 THE PATIENT SAMPLE WAS REPEATED TWICE ON A DIFFERENT C501 MODULE WITH RESULTS OF 146.3 MG/L WITH A DATA FLAG AND 3793.3 MG/L. ON (B)(6) 218 THE RESULT WAS CORRECTED TO 3793.3 MG/L. NO ADVERSE EVENT OCCURRED. THE C501 MODULE SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THAT THE REAGENT WAS FAULTY. THE REAGENT WAS REPLACED AND THE CUSTOMER RAN MULTIPLE SAMPLES AND RECEIVED EXPECTED RESULTS. THE CUSTOMER HAS NOT HAD ANY FURTHER ISSUES SINCE THE REAGENT WAS REPLACED.