ELECSYS ACTH
Received Oct 4, 2024 · Event occurred Aug 16, 2024
Report 1823260-2024-02899 · MDR key 20375350
Device
Generic name
Adrenocorticotropic Hormone (acth) Test System
Manufacturer
Roche DiagnosticsCatalog number
08946728190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
29 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6 INVESTIGATION CONCLUSION CODE WAS UPDATED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A SUSPECTED INTERFERENCE WITH THE ELECSYS ACTH ASSAY. A QUESTIONABLE HIGH ELECSYS ACTH RESULT WAS ALLEGED FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. IT WAS REPORTED THAT THE ALLEGED SAMPLE GENERATED HIGH ACTH RESULTS THAT DID NOT MATCH THE PATIENT'S MEDICAL HISTORY. THE ELECSYS ACTH RESULT ON (B)(6) 2024 WAS 171. THE UNIT OF MEASURE WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE ALLEGED SAMPLE WAS REQUESTED, BUT NOT RECEIVED FOR INVESTIGATION. BASED ON THE LACK OF INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.