MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM

Catalog Number	08890587190
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	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 602 module serial number is (b)(6.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys hcg stat result from one patient sample tested on the cobas e 602 module.On (b)(6) 2025: the initial result of the first patient sample was <1.0 miu/ml with a data flag.The physician questioned the result as they knew the patient was pregnant.The initial result of the second patient sample (undiluted) was >10000 miu/ml with a data flag.The repeat result of the second patient sample (at 1:100 dilution) was 21697 miu/ml or 22000 miu/ml.On (b)(6) 2025: the repeat result of the first patient sample (undiluted) was >10000 miu/ml with a data flag.The repeat result of the first patient sample (at 1:100 dilution) was 21508 miu/ml.The repeat result of the first patient sample (undiluted) was >10000 miu/ml with a data flag.The repeat result of the first patient sample (at 1:100 dilution) was 21986 miu/ml.
Additional Manufacturer Narrative
The investigation reviewed the data set provided by the customer: the qc results were within the specified ranges.The alarm trace had abnormal aspiration alarms surrounding the event; the event was consistent with suboptimal sample quality.The event that occurred on 01-oct-2025 (reported 15-oct-2025) was investigated by the field service engineer.While a definitive root cause was not identified, the system had recently undergone preventative maintenance, and on 14-oct-2025, the measuring cells, syringe seals, and pinch tubing were replaced.To ensure system stability, corrective actions were performed, including the cleaning and inspection of all probes and nozzles, recalibration of gear pump pressures, and adjustment of the mixer paddle cleaning water volume to address an identified insufficiency.On 16-oct-2025, a full instrument check was completed successfully.Validation was further confirmed through a successful precision study.The instrument is verified to be operating within established specifications.A general reagent or analyzer problem was not present, as the qcs before the event were within range.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
• 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: 23498211
• Report Number: 1823260-2025-04545
• Device Sequence Number: 8973647
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203227
• 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): 01/16/2026

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: 02/28/2026
• Device Catalogue Number: 08890587190
• Device Lot Number: 82108001
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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 Sex: Female