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

Model Number	HCG+BETA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hcg+b test system results for 1 patient on a cobas e 411 analyzer (rack system).The initial result was 1.0 miu/ml.On (b)(6) 2025, a new sample was obtained, and the result was 1700 miu/ml.On (b)(6) 2025, the initial sample was repeated, and the result was 250 miu/ml.The repeated result was believed to be correct.The sample was repeated because the initial result did not match the patient's clinical history.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.The field service representative did not find any abnormalities with the analyzer.He performed checks and tests with acceptable results.The investigation did not identify a product problem.

• 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: 21960790
• Report Number: 1823260-2025-01382
• Device Sequence Number: 13058629
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/17/2025

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: 797723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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: 41 YR
• Patient Sex: Female