MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+ BETA; TOTAL HUMAN CHORIONIC GONADOTROPIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

Catalog Number	09744428190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The qc was in range prior to the event.Seventeen sample quality-related alarms occurred on the date of the event: sample short, sample clot, and sample foam.These alarms suggest preanalytical handling issues.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys hcg+ beta result from the cobas e 801 analytical unit for one patient.The initial result was 238 miu/ml.On (b)(6) 2025, a new sample was collected with the result of < 1 miu/ml.The initial sample was repeated, and the result was < 1 miu/ml.
Additional Manufacturer Narrative
In the investigation, pictures provided from the customer's sample camera showed dust and dirt on the active gripper wheels, which is consistent with insufficient analyzer cleanliness.The investigation was unable to determine a direct root cause.A general reagent or analyzer problem was not present because the qc prior to the event was within ranges.

• Brand Name: ELECSYS HCG+ BETA
• Common Device Name: TOTAL HUMAN CHORIONIC GONADOTROPIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23636036
• Report Number: 1823260-2025-04809
• Device Sequence Number: 9317582
• Product Code: DHA
• UDI-Device Identifier: 07613336217535
• UDI-Public: 07613336217535
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003178
• 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): 12/18/2025

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: 09/30/2026
• Device Catalogue Number: 09744428190
• Device Lot Number: 868906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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: 17 YR
• Patient Sex: Female