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	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The customer stated that the patient sample's stability had expired when the reruns were performed.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys hcg+ss test system result from the cobas e 411 analyzer (rack system) for one patient.The initial result of the initial patient sample was 1.01 miu/ml.On (b)(6) 2025: the repeat results of the initial patient sample were 636.4 miu/ml and 628.3 miu/ml.The result of a new patient sample tested at another laboratory was 6564 u/l (or miu/ml).The nurse questioned the result, prompting the rerun.The repeat results were deemed correct, as they matched the patient's clinical data and the result of the new patient sample.
Additional Manufacturer Narrative
Qc was within range prior to the event.No relevant alarms occurred.A field service engineer (fse) evaluated the instrument and found unstable grounding of the reagent carousel.He cleaned the grounding surface and adjusted the sipper probe and mixing paddle.Diagnostic checks were completed and were successful.The investigation determined that a general reagent or analyzer problem was not present because the qc prior to the event was within ranges.The investigation was unable to determine a direct root cause.

• 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: 23335112
• Report Number: 1823260-2025-04250
• Device Sequence Number: 9845979
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/06/2026

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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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 Age: 35 YR
• Patient Sex: Female