ELECSYS ACTH
Received Sep 21, 2023 · Event occurred Aug 14, 2023
Report 1823260-2023-03056 · MDR key 17791014
Device
Generic name
Adrenocorticotropic Hormone (acth) Test System
Manufacturer
Roche DiagnosticsCatalog number
08946728190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON THE CURRENT INFORMATION, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. SAMPLE TYPE AND SAMPLE STABILITY ISSUES COULD NOT BE EXCLUDED. THE SAMPLES WERE REPEATEDLY FROZEN WHICH IS ALLOWED ONLY ONCE PER PRODUCT LABELING AND BEYOND THE STABILITY PER DOCUMENTED IN PRODUCT LABELING WHEN TESTED FOR THE PRELIMINARY INVESTIGATION. CALIBRATION AND QC DATA DO NOT SUGGEST ANY REAGENT ISSUE.
Additional Manufacturer Narrative
G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS 8000 CORE ANALYZER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ACTH ELECSYS E2G RESULTS FROM THE COBAS 8000 CORE ANALYZER. THE RESULTS FROM THE CUSTOMER OVER TIME AFTER LOADING FOR ACTH: 0 MINUTES (SAMPLE 1): 100 PG/ML. 15 MINUTES (SAMPLE-2): 113 PG/ML. 30 MINUTES (SAMPLE-3): 110 PG/ML. ON 7-SEP-2023, THE PRELIMINARY INVESTIGATION TESTED THE SAMPLES ON A COBAS E801 MODULE: SAMPLE 1: 53.0 PG/ML. SAMPLE 2: 71.7 PG/ML. SAMPLE 3: 65.6 PG/ML. BASED ON THE RESULTS, THE CUSTOMER SUSPECTED A NON-SPECIFIC REACTION IN ROCHE ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LAB.