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

Model Number	HCG+BETA
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number is (b)(6).One of the cobas pro analyzers' serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys hcg+b results from three samples (two from the same patient) tested on the cobas e 402 analytical unit and two cobas pro analyzers.On (b)(6) 2025: patient 1 first sample the initial result from the analyzer was 3.82 miu/ml.The first repeat result from the analyzer was 18.5 miu/ml.The second repeat result from the analyzer was 18.6 miu/ml.The third repeat result from another laboratory's cobas pro analyzer was 19.6 miu/ml.Second sample (from the same blood collection).The result from the cobas pro analyzer was 4.06 miu/ml.The high results were deemed correct.Patient 2 first sample on (b)(6) 2025: the results from the cobas pure analyzer using the primary sample tube were 0.351 miu/ml, 0.353 miu/ml, and 0.296 miu/ml.The results from the cobas pure analyzer using an aliquot of the patient sample were 0.344 miu/ml, 0.309 miu/ml, and 0.340 miu/ml.The results from the first cobas pro analyzer using the primary patient sample tube were 43.0 miu/ml and 52.8 miu/ml.The results from the second cobas pro analyzer using the primary patient sample tube were 53.9 miu/ml and 55.6 miu/ml.The results from the first cobas pro analyzer using an aliquot of the patient sample were 0.394 miu/ml and 0.394 miu/ml.The results from the second cobas pro analyzer using an aliquot of the patient sample were 0.399 miu/ml and 0.397 miu/ml.The low results were deemed correct.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the qc results were within the specified ranges.There was no indication of a performance issue with the reagent.The investigation did 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: 23082700
• Report Number: 1823260-2025-03080
• Device Sequence Number: 4645471
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 11/20/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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: PATIENT 2 - UNDER THERAPY WITH "BIOLOGICAL AGENT".
• Patient Sex: Unknown