AMH ELECSYS E2G 100
Received Apr 23, 2024 · Event occurred Jan 17, 2023
Report 1823260-2024-01247 · MDR key 19165279
Device
Generic name
Anti-müllerian Hormone Test System
Manufacturer
Roche DiagnosticsCatalog number
08819319190
Lot number
626160
Product problems
- Low Test Results
- Appropriate Device Problem Term/Code Not Available
- Low Test Results
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6) . THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS AMH ON A COBAS 6000 E601 MODULE. THE CLINICIAN DID NOT AGREE WITH THE MEASURED SAMPLE VALUE. THE SAMPLE RESULTED IN AN AMH VALUE OF 0.22 NG/ML. AFTER THE LOW VALUE, THE PATIENT WAS TREATED WITH PREGOVERIN. ON (B)(6) 2024, ANOTHER SAMPLE FROM THE PATIENT WAS TESTED, RESULTING IN AN AMH VALUE OF 4.67 NG/ML. THE CLINICIAN SUSPECTED THE VALUE FROM (B)(6) 2024 TO BE INCORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT ISSUE CAN BE RULED OUT.