MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+B; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	HCG+BETA
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hcg+beta (hcg+b) assay on a cobas e801 module.Initial result: 546 miu/ml.Since a miscarriage was suspected, the sample was then repeated.1st repeat result: 10000 miu/ml with a data flag.2nd repeat result: 60267 miu/ml, and it was considered a good result.
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
During the evaluation, it was confirmed that the preventive maintenance for both measuring cells, the syringe seals, and the gear pump head was overdue.The field service engineer performed the preventive service maintenance.Qc was performed, and it was within the range.No further issues were reported afterwards.The root cause was traced to maintenance.

• Brand Name: ELECSYS HCG+B
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 22150689
• Report Number: 1823260-2025-01740
• Device Sequence Number: 8308606
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• 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): 07/23/2025

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: 04/30/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 824128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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: 26 YR
• Patient Sex: Female