MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS TEST SYSTEM; 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	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 module serial number was (b)(6).The qc was acceptable.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 6000 e601 module.Sample 1: initial result: 0.275 miu/ml.The patient was sent to the emergency room, where a new sample (sample 2) was drawn and tested, resulting in a different hcg+ss value.The result of sample 2 was not provided.Sample 1 was then repeated twice, resulting in repeat results of 65.14 miu/ml and 64.28 miu/ml.The repeat results of sample 1 and the result of sample 2 were close in values.The repeat results were deemed to be correct.Reportedly, an amended report with the correct results was issued.
Additional Manufacturer Narrative
No relevant alarms occurred.The investigation determined that the customer's centrifugation time and the clotting time may be shorter, and the centrifugation speed may be faster than the recommendations in the guidelines.The field service engineer (fse) found no cause for the issue.He checked the sample probe adjustments, the bead mixer alignment, and tightened the sample probe mechanism set screws.Precision studies, calibration, and qc were performed, and they were within specifications.The fse verified that the instrument was performing within specifications.A general reagent or analyzer problem can be excluded because the qc before the event was within the ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23743617
• Report Number: 1823260-2025-04983
• Device Sequence Number: 8449201
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 01/19/2026

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: 03/31/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 83810505
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/19/2026
• 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 Sex: Unknown