MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS; 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	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Qc was within the assigned ranges on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys hcg+ss assay on a cobas e 801 analytical unit.Patient 1: sample 1: initial result: 60.3 iu/l.On (b)(6) 2025: a new sample (sample 2) was drawn from the patient and tested, resulting in a value of <0.200 iu/l (accompanied by a data flag).Sample 1: repeat result: <0.200 iu/l (accompanied by a data flag).Patient 2: on (b)(6) 2025: sample 1: initial result: 425 iu/l.Repeat result: 0.<200 iu/l (accompanied by a data flag).On (b)(6) 2025: a new sample (sample 2) was drawn from the patient and tested, resulting in a value of <0.200 iu/l (accompanied by a data flag).The results of <0.200 iu/l were deemed to be correct, as patient 1 and patient 2 were confirmed not to be pregnant.
Additional Manufacturer Narrative
The provided sample foam detection images showed no issues with the sample quality and the grippers.There was no hint of a reagent issue.After the field service engineer replaced the measuring cells, the issue was resolved.The investigation did 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23349702
• Report Number: 1823260-2025-04274
• Device Sequence Number: 20822565
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 12/09/2025

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: 09/30/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 868906
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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: Female