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	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 821080.The expiration date was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg+ss test system results for 2 patients from the cobas e411 disk analyzer.The doctor and patients believed the results did not match the clinical picture of the patients.Patient 1: the patient believed she might be pregnant, but the number of months was unknown.The initial result was < 1 uiu/ml, with a data flag.A chromon graphic immunoassay for urine test for beta hcg had a result of "slightly positive".(the lower limit is 25.) the doctor questioned the results and asked for repeat testing.The same sample was repeated, and the result was < 1 uiu/ml with a data flag.Patient 2: the initial result was 18 uiu/ml.A chromon graphic immunoassay for urine test for beta hcg had a negative result.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The field service engineer performed precision testing.The investigation was unable to determine a specific root cause.There was no evidence of a device malfunction.A general reagent or analyzer problem was not present, as the provided calibration and qc data were acceptable.There were no relevant alarms in the analyzer alarm trace.

• 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 46250-0457
• MDR Report Key: 24320558
• Report Number: 1823260-2026-00489
• Device Sequence Number: 15871705
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 03/11/2026

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 Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 821080
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/11/2026
• 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