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

Model Number	HCG+BETA
Medical Device Problem Codes	Low Test Results (2458); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hcg+ss on a cobas pure c 303 analytical unit.The sample initially resulted in hcg+b values of 63.1 miu/ml and > 10000 miu/ml with a data flag.The client complained because the value of 63.1 miu/ml did not match the patient's previous records.The sample was diluted and repeated twice on (b)(6) 2025, resulting in hcg+b values of > 10000 miu/ml with a data flag and 18390 miu/ml.
Additional Manufacturer Narrative
No calibration influence was observed.Controls were within range prior to the event.A general reagent or analyzer problem was not present.Isolated non-reproducible results do not represent a general malfunction of the assay.A review of alarm trace data showed no relevant alarms.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG+SS
• 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: 22786998
• Report Number: 1823260-2025-02463
• Device Sequence Number: 18201902
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 04/30/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 82412802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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 Sex: Unknown