MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS TEST SYSTEM; 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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hcg+b reagent expiration date was not provided.The cobas e411 disk serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hcg+ss test system assay on a cobas e 411 analyzer (disk system).Initial result: 19.49 miu/ml.The nurse questioned the initial result, prompting the repeat of the sample.Repeat result: <0.1 miu/ml (accompanied by a data flag).The repeat result was deemed to be correct.
Additional Manufacturer Narrative
Qc was acceptable.No relevant instrument alarms occurred.The field service engineer (fse) did not identify an instrument issue.Voltages and adjustments were checked with no issues.The fse identified preanalytical sample handling issues: the customer does not invert sample tubes (the tubes require 5-6 inversions), the customer uses a coagulation time of 10 minutes (30 minutes is required, and the customer uses a centrifugation time of 5 minutes (the required time is 10 minutes).The investigation determined the event was due to preanalytical handling issues.

• Brand Name: ELECSYS HCG+SS TEST SYSTEM
• 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: 24452590
• Report Number: 1823260-2026-00700
• Device Sequence Number: 15796707
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 03/20/2026

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 Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 868696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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: 38 YR
• Patient Sex: Female