ELECSYS AMH SYSTEM
Received Mar 26, 2020 · Event occurred Dec 19, 2019
Report 1823260-2020-00858 · MDR key 9885486
Device
Generic name
Anti-müllerian Hormone Test System
Manufacturer
Roche DiagnosticsModel number
AMH PLUSCatalog number
07957246190
Lot number
40818501
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
QUALITY CONTROLS WERE WITHIN RANGE, SHOWING NO INDICATION OF A REAGENT OR INSTRUMENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS AMH PLUS ASSAY ON A COBAS 8000 E 602 MODULE. AN ALIQUOT OF THE SAMPLE INITIALLY RESULTED WITH AN AMH VALUE OF LESS THAN 0.1 PMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AT A DIFFERENT LABORATORY USING AN UNKNOWN METHOD, A SAMPLE FROM THE PATIENT WAS TESTED FOR AMH AND THE RESULT WAS 56 PMOL/L. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE 56 PMOL/L VALUE WAS MEASURED FROM THE SAME PATIENT SAMPLE OR IF IT WAS MEASURED FROM A DIFFERENT SAMPLE COLLECTED FROM THE PATIENT AT A DIFFERENT TIME. THE E 801 ANALYZER SERIAL NUMBER IS (B)(4).