MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	HCG+BETA
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg+ss results from the cobas e 801 analytical unit.The initial result was <1 miu/ml.The er drew a second sample 1 hour later that had a result of 26547 miu/ml.The er department questioned the initial result.The original sample was then repeated with an autodilution, and the result was 30436 miu/ml.This result was believed to be correct.
Additional Manufacturer Narrative
The sfd (sample foam detection) images showed that the majority of the customer¿s 5ml tubes contained droplets on the interior sidewalls.Due to the narrow 10.5 mm internal diameter of these tubes and instances of tubes being tilted within the racks, it is highly probable that these droplets prematurely triggered the liquid level detection (lld).The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.The customer was advised that false bottom tubes (fbt) would reduce the risk of lld interference from sidewall moisture, and for secondary tubes (aliquots), centrifuging after the aliquoting process could effectively clear the sidewalls of any droplets.The field service engineer replaced the sample probes as a preventive measure.There is no evidence to suggest a malfunction of the device.
Additional Manufacturer Narrative
Medwatch field "e4 initial report also send to fda" was updated.

• 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: 23876428
• Report Number: 1823260-2025-05302
• Device Sequence Number: 18507659
• 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): 03/23/2026

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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 03/05/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/25/2026; 03/23/2026
• 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: 25 YR
• Patient Sex: Female