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	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for three samples collected from the same patient and tested with elecsys hcg+b on a cobas e 801 analytical unit.The customer alleges that the change in results between the first sample and the subsequent 2 samples was not clinically possible for the patient.The first sample collected from the patient resulted in an hcg+b value of 2605 miu/ml.A second sample collected from the patient resulted in an hcg+b value of < 0.200 miu/ml with a data flag on (b)(6) 2025.A third sample collected from the patient resulted in an hcg+b value of < 0.200 miu/ml with a data flag on (b)(6) 2025.The customer repeated the first sample on (b)(6) 2025 and it resulted in an hcg+b value of 2531 miu/ml.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue or analyzer issue was not present.Photos of the instrument were provided and these showed dirt/dust on the surface of the instrument.Upon review of the alarm trace, sample foam detection, clot detection, sample short, and abnormal aspiration alarms were observed on the day of the event.The investigation determined the issue is consistent with sample contamination due to dust/dirt on the instrument.Laboratory sample quality was also not optimal.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21867484
• Report Number: 1823260-2025-01190
• Device Sequence Number: 7917134
• 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): 04/25/2025

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: 82412802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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: 34 YR
• Patient Sex: Female