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

Model Number	HCG+BETA
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6) the investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg+b results for 1 patient on a cobas e 402 analytical unit.The initial result was 25.6 miu/ml.A new sample was obtained from the patient, and the result was 3,000 miu/ml.The physician questioned the result from the initial sample and requested that the sample be repeated.On (b)(6) 2025, the initial sample was repeated, and the results were 1864 miu/ml and 1877 miu/ml.The initial sample was repeated on another module, and the result was 1941 miu/ml.The result of 1864 miu/ml was believed to be correct.
Additional Manufacturer Narrative
No calibration influence was observed.The qcs were within the specified ranges.The field service engineer completed the preventative maintenance, cleaned and vacuumed the whole system, and replaced the measuring cell.A general reagent or analyzer problem can be excluded because the qc before the event was within the ranges.Based on the information provided, the investigation did not identify a product problem.The 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: 22212351
• Report Number: 1823260-2025-01852
• Device Sequence Number: 8749249
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/25/2025

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: 79231401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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