TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION
Received Apr 7, 2025 · Event occurred Feb 7, 2025
Report 1823260-2025-01037 · MDR key 21785471
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
800658
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
16 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
WE WERE INFORMED OF NEW QUESTIONABLE RESULTS BY THE CUSTOMER. PATIENT (B)(6) INITIAL RESULT WAS 1306 MG/DL, AND THE REPEAT RESULT WAS 4580 MG/DL. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 2269 MG/DL, AND THE REPEAT RESULT WAS 3494 MG/DL. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 1886 MG/DL, AND THE REPEAT RESULT WAS 4789 MG/DL. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
DURING A SERVICE VISIT ON 13-MAY-2025 THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE WASH VOLUMES, CALIBRATED SAMPLE AND REAGENT NEEDLES, REPLACED THE INTERNAL LENS OF THE BATH, AND VERIFIED THE WASH SOLUTION ASPIRATION. AFTER THESE TASKS WERE COMPLETED, ANOTHER NON-REPEATABLE CASE OCCURRED. PATIENT 6, ON (B)(6) 2025 THE INITIAL RESULT WAS 1891 MG/DL, AND THE REPEAT RESULT WAS 3547 MG/DL. PATIENT 7'S INITIAL RESULT ON (B)(6) 2025 WAS 18 MG/DL, AND THE REPEAT RESULT WAS 4830 MG/DL. PATIENT 8'S INITIAL RESULT ON (B)(6) 2025 WAS 2862 MG/DL, AND THE REPEAT RESULT WAS 1990 MG/DL; ANOTHER REPEAT RESULT WAS 2937 MG/DL. PATIENT 9'S INITIAL RESULT ON (B)(6) 2025 WAS 253 MG/DL, AND THE REPEAT RESULT WAS 4127 MG/DL. PATIENT 10'S INITIAL RESULT ON (B)(6) 2025 WAS 5189 MG/DL. THE 1ST REPEAT RESULT WAS 1603 MG/DL, AND THE 2ND REPEAT RESULT WAS 5195 MG/DL. ON (B)(6) 2025, THE FSE REPLACED ALL OF THE SYRINGES OF THE REAGENT NEEDLES AND SAMPLE NEEDLES. ON 23-MAY-2025, A HARDWARE CHECK WAS COMPLETED AND PASSED. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS DUE TO INADEQUATE PRE-ANALYTICAL HANDLING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION RESULTS FROM THE COBAS 6000 C501 MODULE. PATIENT 1'S INITIAL RESULT WAS 1483 MG/DL, AND THE REPEAT RESULT WAS 4210 MG/DL. PATIENT 2'S INITIAL RESULT WAS 865 MG/DL, AND THE REPEAT RESULT WAS 128 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER WITH A RESULT OF 3907 MG/DL. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED IT WAS LOWER THAN PREVIOUS RESULTS.
Additional Manufacturer Narrative
THE COBAS 6000 C501 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.