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

Catalog Number	08890587190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
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 stat results for 1 patient on a cobas 6000 e601 module.The initial result was 4.92 miu/ml.The sample was retested on another module, and the repeated result was 1 miu/ml.This result was believed to be correct.The sample was repeated because the patient had a negative urine screen result.
Additional Manufacturer Narrative
The qc was within the customer's range.The field service engineer (fse) inspected the analyzer and found no hardware issues.He confirmed that water and gear pump pressures were within specifications, inspected the syringes, and found no issues.The fse cleaned all probes and verified that adjustments were within specifications.He confirmed that reagents/consumables were all in their correct positions.The fse performed mechanism checks and found no signs of leakage.He did a performance check and precision studies, and they were within specifications.The customer loaded a new pack (from a different shipment) and recalibrated on (b)(6) 2025, and the calibration was within ranges.No further issues were reported afterward.The investigation did not identify a product problem.The cause was traced to transportation/storage issues.
Additional Manufacturer Narrative
The successful calibration on 04-jul-2025, was performed with the new calibrator made with fresh di water.The issue was resolved after the customer used new di water to make new calibrators.The investigation did not identify a product problem.The investigation did not identify a specific cause of the event.

• 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: 22608313
• Report Number: 1823260-2025-02282
• Device Sequence Number: 21217205
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 02/28/2026
• Device Catalogue Number: 08890587190
• Device Lot Number: 82108000
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 11/19/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/28/2025; 11/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CEPHALEXIN 500MG; HYDROCODONE-ACETAMINOPHE; KETOROLAC 10MG; PROMETHAZINE 25MG; TAMSULOSIN 0.4MG
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 59 KG