ELECSYS AMH SYSTEM
Received May 28, 2019 · Event occurred May 1, 2019
Report 1823260-2019-01985 · MDR key 8647530
Device
Generic name
Anti-müllerian Hormone Test System
Manufacturer
Roche DiagnosticsModel number
AMHCatalog number
07957190190
Lot number
369817
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
THE CALIBRATION DATA INDICATES THE AFFECTED REAGENT KIT WAS IN USE SINCE (B)(6) 2019. THE KIT¿S ONBOARD STABILITY EXPIRED ON 01-MAY-2019, THE VALIDITY OF PATIENT RESULTS CANNOT BE ENSURED. QC IS PERFORMED SPORADICALLY, NO VALID QC IS AVAILABLE. BASED ON THE LIMITED DATA PROVIDED, A CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS AMH PLUS RESULTS FOR 1 PATIENT TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER AND A COBAS 8000 E 602 MODULE. THIS MEDWATCH WILL COVER THE QUESTIONABLE RESULTS ON THE E 411. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE QUESTIONABLE RESULTS ON THE E 602. ON (B)(6) 2019 THE AMH RESULT IN A DIFFERENT LABORATORY ON THE E 602 WAS 27.7 PMOL/L. ON (B)(6) 2019 THE AMH RESULT ON THE E 411 WAS 10.11 PMOL/L. IT WAS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE AMH REAGENT LOT NUMBER ON THE E 411 WAS 369817. THE EXPIRATION DATE WAS NOT PROVIDED. THE AMH REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THE E 602 WAS NOT PROVIDED.