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

Model Number	HCG+BETA
Medical Device Problem Codes	False Negative Result (1225); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).
Event or Problem Description
We received an allegation of a low result not corresponding to the clinical picture for 1 patient sample tested for elecsys hcg+b (hcg+b) on a cobas e 402 analytical unit.The result from the e402 analyzer was < 1 miu/ml.The physician questioned this result.The patient had been tested "a few days" before the low result, and the result was "positive." the actual result was not provided.The patient was tested again "a few days" after the low result, and the result was "positive." the actual result was not provided.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The field service engineer (fse) checked the patient sample.The sample in question was repeated with expected results.A 21-cup precision was performed with results within specification.Based on the information provided, a general reagent issue can be excluded.The event is consistent with a sample handling issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: ELECSYS HCG+B
• 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: 22028257
• Report Number: 1823260-2025-01508
• Device Sequence Number: 8160830
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/04/2025

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: 09/30/2025
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 792314
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/04/2025
• 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: Unknown