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

Model Number	HCG+BETA
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys hcg+ss test system on a cobas e411 disk.The first patient sample initially resulted in an hcg+b value of 0.381 miu/ml with a data flag indicating carryover.The physician questioned the result because the patient's previous result was in the thousands.The sample was repeated, resulting in a value of 5052 miu/ml with a data flag.The second patient sample initially resulted in an hcg+b value of 185.5 miu/ml with a data flag.The customer repeated this sample due to the first value from the first sample being questioned.The sample was repeated twice, resulting in values of 31.21 miu/ml with a data flag and 192.9 miu/ml with a data flag.The initial value of 185.5 miu/ml was deemed correct.
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The customer stated they had issues with analyzer liquid level detection that week.They did not observe bubbles in the reagent pack.The customer replaced reagent packs and calibration and controls passed.The customer primed the sample probe and it worked fine for a few samples, but liquid level detection errors returned.Controls were within range prior to the event.The field service engineer adjusted the pipettor wash water.The measuring cell, gear pump, and rinse tubing were replaced.Preventive maintenance was performed on the analyzer.The analyzer was working within specifications after the service actions were performed.The investigation determined the service actions resolved the issue.The issue is consistent with insufficient maintenance.

• 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: 23769327
• Report Number: 1823260-2025-05035
• Device Sequence Number: 13178520
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/10/2025

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 Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 868696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/10/2025
• 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: ASPIRIN (SECOND PATIENT); ESTRACE ORAL - 2 TO 3 X DAILY (SECOND PATIENT); ESTRACE PATCHES - EVERY 3RD DAY (SECOND PATIENT); LOVENOX DAILY (SECOND PATIENT); NO MEDICATIONS (FIRST PATIENT); PROGESTERONE INJECTION DAILY (SECOND PATIENT)
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 73 KG