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

Model Number	HCG+BETA
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys hcg+b (hcg + b) on a cobas e 801 analytical unit.The initial result was 2196 miu/ml.This result was questioned based on the patient¿s previous results, and the sample was repeated.The repeat result was 20.7 miu/ml.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Multiple sample quality-related alarms occurred on the date of the event.Pictures of the analyzer show some crystallization in the sipper stations.The field service engineer (fse) checked the instrument for sample probe or pipetting issues, and no issues were identified.The sample coagulation time was 30 minutes.This time may be short if the patient takes anti-coagulants.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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: 22751889
• Report Number: 1823260-2025-02425
• Device Sequence Number: 8634027
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• 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): 09/08/2025

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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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 Sex: Unknown