ALBT2
Received Oct 4, 2023 · Event occurred Aug 24, 2023
Report 1823260-2023-03181 · MDR key 17870013
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
08056722190
Lot number
71222401
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE, CHECKED THE CELL WASH STATION, CLEANED THE FLOW PATH, READJUSTED A PROBE, AND VERIFIED RINSING VOLUMES FOR THE MEASURING CELLS. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 ALBUMIN GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THE RESULTS WERE NOT CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES. ON (B)(6) 2023, SAMPLE 1 HAD AN INITIAL RESULT OF 3.77 G/L. THE REPEAT RESULT WAS 39.9 G/L. ON (B)(6) 2023, SAMPLE 2 HAD AN INITIAL RESULT OF <3 G/L WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 20 G/L AND 20 G/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE MEDICAL CODING IN THIS CASE HAS BEEN UPDATED.