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	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a false negative elecsys hcg+ss result for 1 patient sample on a cobas e 801 analytical unit.On (b)(6) 2025, the initial result was <1 miu/ml.On (b)(6) 2025, the sample was repeated and the result was 74383 miu/ml.
Additional Manufacturer Narrative
The reagent lot number is 824128.The expiration date was not provided.The field service engineer (fse) performed periodic maintenance and replaced the measuring cell.An instrument check and qc were performed successfully.The investigation is ongoing.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.The calibration recovery data provided was within specification.The qc recovery data provided showed that the customer's recovery for level 3 was outside of 2 standard deviations on the day of the event.The alarm trace showed sample foam detection and sample short errors.The field service engineer (fse) performed flow path, wash station, and tubing decontamination, replaced seals, pinch tubing, and waste chutes, and checked the main pump and gear head pressures.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.
Additional Manufacturer Narrative
Section e4 was updated.The customer reported the event through the fda's medwatch program.The medwatch report reference number is (b)(4).Sections a2 and a3a were updated.Due to a response on the medwatch report, the customer was contacted by roche for clarification.The customer confirmed that there was no patient harm, as all results were caught by the clinicians.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 23085559
• Report Number: 1823260-2025-03114
• Device Sequence Number: 9848718
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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: 82412801
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 03/11/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/09/2025; 03/30/2026
• 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: 22 YR
• Patient Sex: Female