MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS; 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	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).Calibration and controls were acceptable.Upon review of the alarm trace data, there were no relevant alarms around the time of the complained result.Two sample related alarms were observed on the trace data (sample short and sample foam detection).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hcg+ss on a cobas e 801 analytical unit.The sample initially resulted in an hcg+b value of < 0.200 miu/ml with a data flag.This value was reported in the customer's laboratory information system as < 2.00 miu/ml.The patient previously tested positive for pregnancy.The patient was not satisfied with the initial result, so the patient went to another hospital where they were tested with an unknown method and had a positive hcg+b result.The patient's sample was repeated on (b)(6) 2025, resulting in an hcg+b value of > 10000 miu/ml with a data flag.The sample was diluted 1:100 and repeated, resulting in a value of 90827 miu/ml on (b)(6) 2025.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue can be ruled out.Isolated non-reproducible results do not represent a general malfunction of the assay.Upon review of alarm trace data, there were no relevant alarms around the time of the complained result.Two sample related alarms (sample short and sample foam detection) were observed on the trace data.The field service engineer performed preventive maintenance on the analyzer.The instrument was performing acceptably.Upon review of images captured by the sample foam detection camera, some dust on the gripper was visible.Sample images showed questionable sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG+SS
• 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: 21516538
• Report Number: 1823260-2025-00620
• Device Sequence Number: 8454874
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/03/2025

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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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: 24 YR
• Patient Sex: Female