MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AMH; ANTI-MÜLLERIAN HORMONE TEST SYSTEM

Catalog Number	08819378190
Medical Device Problem Codes	High Test Results (2457); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.No sample inversions were performed and the customer used a clotting time of "up to 15 minutes." the customer used a centrifugation time of 5 minutes at a speed of 4000 revolutions per minute (rpm).The clotting and centrifugation times may be too short.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys amh (amh) on a cobas e 402 analytical unit.The initial result was 17.4 ng/ml.The repeat result was < 0.0100 ng/ml with a data flag.The patient was tested in a different laboratory and the result from the maglumi method was 0.049 ng/ml.The original sample was repeated at the laboratory using the maglumi method and the repeat result was 0.056 ng/ml.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The investigation determined the event was consistent with a pre-analytical handling issue (no tube inversions after draw, too short clotting time and possibly improper centrifugation).

• Brand Name: ELECSYS AMH
• Common Device Name: ANTI-MÜLLERIAN HORMONE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21305729
• Report Number: 1823260-2025-00326
• Device Sequence Number: 8848138
• Product Code: PQO
• UDI-Device Identifier: 07613336166291
• UDI-Public: 07613336166291
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: DEN150057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 08819378190
• Device Lot Number: 786819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female