MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+B 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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 - cobas e 602 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys hcg+b result from one patient sample tested on the cobas 8000 - cobas e 602 module.The initial result was 0.621 miu/ml.The repeat result was 68,806 miu/ml.The doctor questioned the initial result, prompting the rerun of the patient sample.The repeat result was deemed correct.
Additional Manufacturer Narrative
The calibration and qc were acceptable.The alarm trace did not indicate any issues.The field service engineer inspected the module and did not find any cause for the event.He verified the sample probe adjustments, performed liquid-level detection adjustments, and cleaned the probes.He performed preventative maintenance and replaced parts as part of the said maintenance.He performed an assay precision study with successful results.A general reagent or analyzer problem was not detected because the qc before the event was within range and isolated non-reproducible results do not represent a general malfunction of the assay.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG+B 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21917476
• Report Number: 1823260-2025-01291
• Device Sequence Number: 21088159
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/23/2025

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: 10/31/2025
• Device Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 79772305
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/23/2025
• 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 Age: 27 YR
• Patient Sex: Female