ELECSYS TACROLIMUS
Received Feb 4, 2025 · Event occurred Jan 13, 2025
Report 1823260-2025-00330 · MDR key 21307380
Device
Generic name
Tacrolimus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07251254190
Lot number
75323400
Product problems
- Low Test Results
- Output Problem
- Non Reproducible Results
- Low Test Results
- Output Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.5 NG/ML WITH A DATA FLAG. ON (B)(6) 2025, THE REPEAT RESULT WAS 10.1 NG/ML. ON (B)(6) 2025, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS 13.0 NG/ML.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE CALIBRATION RESULTS WERE WITHIN SPECIFICATIONS BUT WERE IN THE LOW RANGE. THE QC WAS WITHIN SPECIFICATIONS ON THE DATE OF EVENT. BASED ON THE "SAMPLE ASPIRATION ALARM" PRESENT DURING SAMPLE PIPETTING, THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.